Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.

To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.

81202Wednesday, October 19, 2016Rules and RegulationsBUREAU OF CONSUMER FINANCIAL PROTECTION12 CFR Part 1006[Docket No. CFPB-2014-0033]RIN 3170-AA49Safe Harbors From Liability Under the Fair Debt Collection Practices Act for Certain Actions Taken in Compliance With Mortgage Servicing Rules Under the Real Estate Settlement Procedures Act (Regulation X) and the Truth in Lending Act (Regulation Z)AGENCY:

Bureau of Consumer Financial Protection.

ACTION:

Official Bureau interpretations.

SUMMARY:

The Bureau of Consumer Financial Protection (Bureau) is issuing this interpretive rule under the Fair Debt Collection Practices Act (FDCPA) to clarify the interaction of the FDCPA and specified mortgage servicing rules in Regulations X and Z. This interpretive rule constitutes an advisory opinion for purposes of the FDCPA and provides safe harbors from liability for servicers acting in compliance with specified mortgage servicing rules in three situations: Servicers do not violate FDCPA section 805(b) when communicating about the mortgage loan with confirmed successors in interest in compliance with specified mortgage servicing rules in Regulation X or Z; servicers do not violate FDCPA section 805(c) with respect to the mortgage loan when providing the written early intervention notice required by Regulation X to a borrower who has invoked the cease communication right under FDCPA section 805(c); and servicers do not violate FDCPA section 805(c) when responding to borrower-initiated communications concerning loss mitigation after the borrower has invoked the cease communication right under FDCPA section 805(c).

DATES:

This rule is effective on October 19, 2017, except that the interpretation contained in Part II.A is effective on April 19, 2018.

In January 2013, the Bureau issued several final rules concerning mortgage markets in the United States (2013 Title XIV Final Rules), pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act), Public Law 111-203, 124 Stat. 1376 (2010). Two of these rules were (1) the Mortgage Servicing Rules Under the Real Estate Settlement Procedures Act (Regulation X) (2013 RESPA Servicing Final Rule); 1 and (2) the Mortgage Servicing Rules Under the Truth in Lending Act (Regulation Z) (2013 TILA Servicing Final Rule).2

1 78 FR 10695 (Feb. 14, 2013).

2 78 FR 10901 (Feb. 14, 2013).

The Bureau clarified and revised those rules through notice and comment rulemaking during the summer and fall of 2013 in the (1) Amendments to the 2013 Mortgage Rules under the Real Estate Settlement Procedures Act (Regulation X) and the Truth in Lending Act (Regulation Z) (July 2013 Mortgage Final Rule) 3 and (2) Amendments to the 2013 Mortgage Rules under the Equal Credit Opportunity Act (Regulation B), Real Estate Settlement Procedures Act (Regulation X), and the Truth in Lending Act (Regulation Z) (September 2013 Mortgage Final Rule).4 In October 2013, the Bureau clarified compliance requirements in relation to successors in interest, early intervention requirements, bankruptcy law, and the Fair Debt Collection Practices Act (FDCPA) 5 through an Interim Final Rule (IFR) 6 and a contemporaneous compliance bulletin (October 2013 Servicing Bulletin).7 Among other things, the IFR provisionally exempted servicers from the early intervention requirements when a borrower has properly invoked the FDCPA's cease communication protections and indicated that the Bureau expected to explore the potential utility and application of such requirements in comparison to the FDCPA protections in a broader debt collection rulemaking.8 In October 2014, the Bureau added an alternative definition of small servicer in the Amendments to the 2013 Mortgage Rules under the Truth in Lending Act (Regulation Z).9 The purpose of each of these updates was to address important questions raised by industry, consumer advocacy groups, and other stakeholders.

8 78 FR 62993, 62994 (Oct. 23, 2013). The Bureau received comments in response to the IFR that it took into account in developing the proposed rule and sample forms for consumers in bankruptcy.

9 79 FR 65300, 65304 (Nov. 3, 2014).

A. Proposed Rule

On December 15, 2014, the Bureau published for notice and comment a proposed rule to amend Regulations X and Z.10 Among other things, the Bureau proposed three sets of rules relating to successors in interest. First, the Bureau proposed rules to define successors in interest for purposes of Regulation X's subpart C and Regulation Z as those persons who acquired an ownership interest in the property securing a mortgage loan in a transfer protected from due-on-sale enforcement by the Garn-St Germain Depository Institutions Act of 1982. Second, the Bureau proposed rules relating to how a mortgage servicer confirms a successor in interest's identity and ownership interest in the property. Third, the Bureau proposed to apply specified mortgage servicing rules in Regulations X and Z to successors in interest whose identity and ownership interest in the property have been confirmed by the servicer. The Bureau proposed these changes to address the significant problems that successors in interest continue to encounter with respect to the servicing of mortgage loans secured by their property—such as lack of access to information about the mortgage loan—which can lead to unnecessary foreclosures.

10 79 FR 74176 (Dec. 15, 2014).

The Bureau also proposed to maintain the IFR's exemption from the live contact requirements of § 1024.39(a) with regard to a mortgage loan for which a borrower has invoked the cease communication protections of FDCPA section 805(c), for a servicer subject to the FDCPA with respect to that loan, while partially eliminating the exemption from the written early intervention notice requirements of § 1024.39(b) to require that a servicer provide a modified written notice to the borrower, if loss mitigation options are available. In addition to the information set forth in § 1024.39(b)(2), the proposal would have required that the modified written early intervention notice include a statement that the servicer may or intends to invoke its specified remedy of foreclosure.

B. Final Rule

Concurrent with issuing this interpretive rule, the Bureau is finalizing the proposed changes described above, with certain adjustments in the Amendments to the 2013 Mortgage Rules under the Real Estate Settlement Procedures Act (Regulation X) and the Truth in Lending Act (Regulation Z) (2016 Servicing Final Rule).11 Among other things, the 2016 Servicing Final Rule includes the proposed three sets of rule changes relating to successors in interest, with modifications to address concerns raised in comments the Bureau received. First, the 2016 Servicing Final Rule adds definitions of successor in interest to Regulations X and Z that are modeled on the categories of transferees that are protected from due-on-sale enforcement by the Garn-St Germain Depository Institutions Act of 1982.12 Consistent with the proposal, successors in interest, as defined in the 2016 Servicing Final Rule, will not necessarily have assumed the mortgage loan obligation (i.e., legal liability for the mortgage debt) under State law or otherwise be legally obligated on the mortgage loan.

Second, the 2016 Servicing Final Rule includes new rules relating to how a mortgage servicer confirms a successor in interest's identity and ownership interest. It also defines confirmed successor in interest under subpart C of Regulation X and under Regulation Z as a successor in interest once a servicer has confirmed the successor in interest's identity and ownership interest in the relevant property.

Third, the 2016 Servicing Final Rule provides that a confirmed successor in interest is considered a borrower for purposes of Regulation X subpart C and § 1024.17 and a consumer for purposes of Regulation Z §§ 1026.20(c) through (e), 1026.36(c), 1026.39, and 1026.41 (collectively referred to herein as the Mortgage Servicing Rules). Under the 2016 Servicing Final Rule, confirmed successors in interest can obtain information about the mortgage loan through requests for information and notice of error procedures.13 Confirmed successors in interest are also generally entitled to receive notices required under the Mortgage Servicing Rules to the extent applicable, if the servicer is not providing the same specific notices to another borrower on the account.14 Applying these protections to confirmed successors in interest will further the purposes of RESPA and TILA by helping to prevent unnecessary foreclosures and other consumer harm by keeping confirmed successors in interest informed of the status of the mortgage loans on their property.

13 The 2016 Servicing Final Rule provides that, in responding to a request for information under § 1024.36 or a request for documentation under § 1024.35(e)(4), a servicer may omit location and contact information and personal financial information (other than information about the terms, status, and payment history of the mortgage loan) if: (i) The information pertains to a potential or confirmed successor in interest who is not the requester; or (ii) the requester is a confirmed successor in interest and the information pertains to any borrower who is not the requester.

14 The same exemptions and scope limitations apply to confirmed successors in interest as to other borrowers under the Mortgage Servicing Rules. Additionally, if a servicer provides an initial written notice and acknowledgment form to a confirmed successor in interest upon confirmation in compliance with the requirements of Regulation X § 1024.32(c)(1) through (3), the 2016 Servicing Final Rule allows the servicer not to provide notices under the Mortgage Servicing Rules to the confirmed successor in interest until the confirmed successor in interest requests such notices through the acknowledgment.

The 2016 Servicing Final Rule also finalizes the proposed partial exemption from the early intervention requirements with regard to a mortgage loan for which any borrower has invoked the cease communication right pursuant to FDCPA section 805(c), for a servicer subject to the FDCPA with respect to that loan, with modifications to address concerns raised in comments the Bureau received. Under the 2016 Servicing Final Rule, if a borrower has invoked the cease communication right pursuant to FDCPA section 805(c), a servicer subject to the FDCPA with respect to that loan is exempt from the live contact requirements with respect to that mortgage loan. If no loss mitigation option is available or while any borrower on the mortgage loan is a debtor in bankruptcy under title 11 of the United States Code, a servicer is also exempt from the written notice requirements with respect to that mortgage loan. If these conditions are not met, the servicer is required to provide a modified written early intervention notice pursuant to § 1024.39(d)(3), as described in more detail below.

II. Application of Interpretive Rule

While many mortgage servicers are not subject to the FDCPA, mortgage servicers that acquired a mortgage loan at the time that it was in default are subject to the FDCPA with respect to that mortgage loan. The Bureau is issuing this interpretive rule to clarify the interaction between certain provisions of the FDCPA and the Mortgage Servicing Rules. This interpretive rule constitutes an advisory opinion under FDCPA section 813(e) and provides a safe harbor from liability for actions done or omitted in good faith in conformity with the opinion, even if the opinion is rescinded or amended in whole or in part after the act or omission occurs, or is determined invalid by a judicial authority.15 The interpretations contained in this rule are included in relevant commentary to Regulations X and Z.16

In the 2016 Servicing Final Rule, the Bureau is extending certain protections of Regulations X and Z to cover confirmed successors in interest whether or not a successor has assumed the mortgage loan obligation.17 For example, servicers generally will have to comply with Regulation X's requirements for loss mitigation and Regulation Z's requirements for periodic statements with respect to confirmed successors in interest.18 This interpretive rule clarifies the interaction between the requirements in the 2016 Servicing Final Rule applicable to confirmed successors in interest and FDCPA section 805(b)'s general prohibition on communicating with third parties in connection with collection of a debt.

A person to whom an ownership interest in a property securing a mortgage loan subject to this subpart is transferred from a borrower, provided that the transfer is:

• A transfer by devise, descent, or other operation of law on the death of a joint tenant or tenant by the entirety;

• A transfer to a relative resulting from the death of a borrower;

• A transfer where the spouse or children of the borrower become an owner of the property;

• A transfer resulting from a decree of a dissolution of marriage, legal separation agreement, or from an incidental property settlement agreement, by which the spouse of the borrower becomes an owner of the property; or

• A transfer into an inter vivos trust in which the borrower is and remains a beneficiary and which does not relate to a transfer of rights of occupancy in the property.

Regulation X § 1024.31. The 2016 Servicing Final Rule's definition of successor in interest for Regulation Z is identical, except that the Regulation Z definition substitutes “a dwelling securing a closed-end consumer credit transaction is transferred from a consumer” for “a property securing a mortgage loan is transferred from a borrower.” Regulation Z § 1026.2(27)(i). The categories included in these definitions track the categories of transfers protected by section 341(d) of the Garn-St Germain Depository Institutions Act of 1982. The 2016 Servicing Final Rule also defines confirmed successor in interest as a successor in interest once a servicer has confirmed the successor in interest's identity and ownership interest in the relevant property. Regulation X § 1024.31, Regulation Z § 1026.2(a)(27)(ii).

FDCPA section 805(b) generally prohibits debt collectors from communicating with third parties in connection with the collection of a debt in the absence of a court order or prior consumer consent given directly to the debt collector. FDCPA section 805(b) permits debt collectors to communicate with a person who is a consumer for purposes of section 805. FDCPA section 805(d), in turn, states that the term consumer for purposes of section 805 includes the consumer's spouse, parent (if the consumer is a minor), guardian, executor, or administrator.19 The use of the word “includes” indicates that section 805(d) is an exemplary rather than exhaustive list of the categories of individuals that are “consumers” for purposes of FDCPA section 805.

FDCPA section 805 thus recognizes the importance of permitting debt collectors to communicate with a narrow category of other persons who, by virtue of their relationship to the obligor or the debt in question, may need to communicate with the debt collector in connection with the collection of the debt.

In light of its expertise as the agency that Congress has charged with interpreting and implementing the FDCPA, RESPA, and TILA, the Bureau interprets the term consumer for purposes of FDCPA section 805 to include a confirmed successor in interest as that term is defined in Regulation X § 1024.31 and Regulation Z § 1026.2(a)(27)(ii). Given their relationship to the obligor, the mortgage loan, and the property securing the mortgage loan, and given the Bureau's extension of certain protections of Regulations X and Z to them, the Bureau concludes that confirmed successors in interest are—like the narrow categories of persons enumerated in FDCPA section 805(d)—the type of individuals with whom a servicer needs to communicate about the mortgage loan. As the Bureau notes in the 2016 Servicing Final Rule, a servicer's failure to provide information to a successor in interest about the status of a mortgage loan or to evaluate the successor in interest for available loss mitigation options could result in unnecessary foreclosure and loss of the successor in interest's ownership interest. Under this interpretive rule, servicers subject to the FDCPA with respect to a mortgage loan do not violate FDCPA section 805(b)'s prohibition on communicating with third parties by communicating with a confirmed successor in interest about a mortgage loan secured by property in which the confirmed successor in interest has an ownership interest, in compliance with the Mortgage Servicing Rules.20

20 As a consequence of this interpretation, the protections in FDCPA sections 805(a) and (c), which apply to consumers for purposes of section 805, apply to confirmed successors in interest. Under FDCPA section 805(a), a debt collector may not—without the prior consent of the consumer or the express permission of a court—communicate with the consumer in connection with the collection of any debt in certain circumstances, including at any unusual or inconvenient time or place. And, as explained in greater detail below, FDCPA section 805(c) provides that, if a consumer refuses in writing to pay a debt or requests that a debt collector cease communicating with the consumer about the debt, the debt collector must generally cease communicating with the consumer.

Because this interpretive rule applies only to the use of the term consumer in section 805, it does not affect the definition of consumer under the remaining FDCPA provisions. Moreover, this interpretive rule applies only to confirmed successors in interest as defined in Regulation X § 1024.31 and Regulation Z § 1026.2(a)(27)(ii) to facilitate their access to information about the mortgage loan encumbering their property. It does not expand the definition of consumer for purposes of FDCPA section 805 beyond confirmed successors in interest as defined in Regulations X and Z. Furthermore, this interpretation does not relieve servicers that are debt collectors of their obligations under the FDCPA, including their obligations under FDCPA sections 806 through 808.21

21 For example, servicers that are debt collectors must not: Engage in conduct the natural consequence of which is to harass, oppress, or abuse any person in connection with the collection of a debt; use any false, deceptive, or misleading representation or means in connection with the collection of a debt; or use unfair or unconscionable means to collect or attempt to collect any debt.

B. Required Early Intervention Notice

As explained in the 2016 Servicing Final Rule, the Bureau is, in part, eliminating the exemption from the written early intervention requirements with regard to a mortgage loan for which any borrower has invoked the cease communication right under FDCPA section 805(c), for a servicer subject to the FDCPA with respect to that loan. A servicer that is a debt collector with respect to that loan is exempt from the written notice requirements with regard to that loan if no loss mitigation option is available 22 or while any borrower on the mortgage loan is a debtor in bankruptcy under title 11 of the United States Code. If these conditions are not met, the servicer is required to provide a modified written early intervention notice that, among other things, includes statements encouraging the borrower to contact the servicer, provides a brief description of examples of loss mitigation options that may be available from the servicer, and states that the servicer may or intends to invoke its specified remedy of foreclosure.23 The servicer is legally required to provide a delinquent borrower with the written notice not later than the 45th day of the borrower's delinquency. As a general matter, this written notice must be provided well before the servicer may initiate foreclosure: In most cases, the servicer is legally required to wait until a borrower's mortgage loan obligation is more than 120 days delinquent, after the written notice has been sent, to make the first notice or filing required by applicable law for any judicial or non-judicial foreclosure process. This written notice may not contain a request for or suggestion of payment, other than for purposes of loss mitigation, and the servicer is not required to provide it to the borrower more than once during any 180-day period.24

23 Regulation X § 1024.39(d)(3). The 2016 Servicing Final Rule provides the following model language that servicers that are debt collectors may use:

This is a legally required notice. We are sending this notice to you because you are behind on your mortgage payment. We want to notify you of possible ways to avoid losing your home. We have a right to invoke foreclosure based on the terms of your mortgage contract. Please read this letter carefully.

Appendix MS-4(D). Use of this model clause or another statement in compliance with § 1024.39(d)(3)(i), on a written notice as required by and in compliance with the other requirements of § 1024.39(d)(3), provides a safe harbor from FDCPA liability under section 805(c) for providing the required statement.

24 Regulation X § 1024.39(d)(3).

Section 805(c) of the FDCPA provides that, if a consumer refuses in writing to pay a debt or requests that a debt collector cease communicating with the consumer about the debt, the debt collector must discontinue communicating with the consumer, subject to enumerated exceptions. As relevant here, the prohibition does not apply where a debt collector communicates with a consumer who has invoked the cease communication right to notify the consumer that the debt collector or creditor may invoke specified remedies which are ordinarily invoked by such debt collector or creditor 25 or, where applicable, to notify the consumer that the debt collector or creditor intends to invoke a specified remedy.26

25 FDCPA section 805(c)(2).

26 FDCPA section 805(c)(3).

Because failure to provide the written early intervention notice required by § 1024.39(d)(3) is closely linked to a servicer's ability to invoke its specified remedy of foreclosure, the Bureau concludes that the notice falls within the exceptions in FDCPA sections 805(c)(2) and (3).

This interpretation is limited to the specific situation where a servicer that is a debt collector with respect to a mortgage loan is required by § 1024.39(d)(3) to provide a modified written early intervention notice to a borrower who has invoked the cease communication right under FDCPA section 805(c) with regard to that loan. It is a narrow safe harbor, based only upon the interplay between these two specific federal consumer protections—the early intervention requirements of § 1024.39 of Regulation X and the cease communication provision and statutory exceptions of section 805(c) of the FDCPA. All other provisions of the FDCPA, including the prohibitions contained in FDCPA sections 805 through 808, are unaffected by this interpretation, and a servicer that is a debt collector with respect to the particular mortgage loan remains liable to the extent that anything in the notice violates any other provision of the FDCPA.27

27 For example, servicers that are debt collectors must not: Engage in conduct the natural consequence of which is to harass, oppress, or abuse any person in connection with the collection of a debt; use any false, deceptive, or misleading representation or means in connection with the collection of a debt; or use unfair or unconscionable means to collect or attempt to collect any debt.

The Bureau concludes that, in the limited circumstances where a servicer is subject to the FDCPA with respect to a borrower's mortgage loan and the borrower has invoked the cease communication right pursuant to FDCPA section 805(c) with regard to that mortgage loan, and where the servicer complies with the requirements of the modified written early intervention notice under § 1024.39(d)(3) of Regulation X, the modified written early intervention notice required under § 1024.39(d)(3) is within the statutory exceptions of FDCPA section 805(c)(2) and (3) and thus does not violate section 805(c) with respect to the mortgage loan.

Even after a borrower has invoked the cease communication right under section 805(c) of the FDCPA, the borrower may contact the servicer to discuss or apply for loss mitigation. For instance, as noted above, § 1024.39(d)(3) requires servicers subject to the FDCPA with respect to a borrower's mortgage loan to provide a written early intervention notice to borrowers who have invoked the FDCPA's cease communication right with regard to that loan if any loss mitigation option is available and no borrower on the mortgage loan is a debtor in bankruptcy under title 11 of the United States Code. The written notice must include a statement encouraging the borrower to contact the servicer.28 The Bureau believes that, when borrowers respond to such a notice by contacting the servicer to discuss available loss mitigation options or otherwise initiate communication with the servicer concerning loss mitigation, such a borrower-initiated communication should not be understood as within the category of communication that borrowers generally preclude by invoking the cease communication right under FDCPA section 805(c). The Bureau therefore concludes that a borrower's invocation of the FDCPA's cease communication right with regard to a mortgage loan does not prevent a servicer that is a debt collector with respect to that mortgage loan from responding to borrower-initiated communications concerning loss mitigation.

28See Regulation X § 1024.39(b)(2)(i).

As noted above, FDCPA section 805(c) empowers borrowers to direct debt collectors to cease contacting them with respect to a debt and frees borrowers from the burden of being subjected to unwanted communications regarding collection of a debt. Borrower-initiated conversations about loss mitigation options do not give rise to the burden of unwanted communications that FDCPA section 805(c) protects against. Rather, they are sought out by borrowers for this narrow purpose. The Bureau therefore concludes that a borrower's cease communication notification pursuant to FDCPA section 805(c) should ordinarily be understood to exclude borrower-initiated communications with a servicer concerning loss mitigation because the borrower has specifically requested the communication at issue to discuss available loss mitigation options. Accordingly, when a servicer that is a debt collector with respect to a mortgage loan responds to a borrower-initiated communication concerning loss mitigation after the borrower's invocation of FDCPA section 805(c)'s cease communication protection with regard to that loan, the servicer does not violate FDCPA section 805(c) with respect to such communications as long as the servicer's response is limited to a discussion of any potentially available loss mitigation option. For example, a servicer may discuss with a borrower any available loss mitigation option that the owner or assignee of the borrower's mortgage loan offers, instructions on how the borrower can apply for loss mitigation, what documents and information the borrower would need to provide to complete a loss mitigation application, and the potential terms or details of a loan modification program, including the monthly payment and duration of the program. These borrower-initiated communications, although variable, are unlikely to be perceived as within the scope of the cease communication request given the borrower's initiation of communications concerning loss mitigation information.

This is the case even if the borrower provides a cease communication notification during the loss mitigation application and evaluation process under § 1024.41. The borrower usually should be understood to have excluded the loss mitigation application and evaluation process under § 1024.41 from the general request to cease communication, and therefore a servicer should continue to comply with the procedures under § 1024.41. Only if the borrower provides a communication to the servicer specifically withdrawing the request for loss mitigation does the cease communication prohibition apply to communicating about the specific loss mitigation action.29

The Bureau notes that this interpretation provides a safe harbor from FDCPA section 805(c) for servicers that are debt collectors with respect to a particular mortgage loan communicating with the borrower in connection with a borrower's initiation of communications concerning loss mitigation. Preceding a borrower's loss mitigation application and during the evaluation process, a servicer may respond to borrower inquiries about potentially available loss mitigation options and provide information regarding any available option. Similarly, if that borrower submits a loss mitigation application, the servicer's reasonable diligence obligations under § 1024.41(b)(1) require the servicer to request additional information from the borrower, including by contacting the borrower, and these communications by the servicer to complete a loss mitigation application do not fall within the cease communication prohibition. The servicer may also seek information that will be necessary to evaluate the borrower for loss mitigation, though the servicer may not seek a payment unrelated to the purpose of loss mitigation. Once the borrower's loss mitigation application is complete, a servicer's communications with a borrower in accordance with the procedures in § 1024.41 are not subject to liability under FDCPA section 805(c) because they arise from the borrower's application for loss mitigation.

The Bureau recognizes that, in order for a borrower to engage in meaningful loss mitigation discussions with a servicer, the servicer may discuss repayment options, the borrower's ability to make a payment, and how much the borrower can afford to pay as a part of a loss mitigation option for which the servicer is considering the borrower. Furthermore, the Bureau understands that any offer for a loan modification or repayment plan is likely to include a specific payment amount the borrower must pay under the terms of the loss mitigation agreement. Such communications, as long as for the purpose of loss mitigation, are permissible because they should not be understood as within the scope of the cease communication request.

The Bureau emphasizes, however, that the cease communication prohibition continues to apply to a servicer's communications with a borrower about payment of the mortgage loan that are outside the scope of loss mitigation conversations. The Bureau's interpretation does not protect a servicer that is a debt collector with respect to a mortgage loan and is using borrower-initiated communications concerning loss mitigation as a pretext for debt collection in circumvention of a borrower's invoked cease communication right under FDCPA section 805(c) with regard to that loan. Seeking to collect a debt under the guise of a loss mitigation conversation is not exempt from liability under FDCPA section 805(c) under this interpretation. Thus, in subsequently communicating with a borrower concerning loss mitigation, the servicer is strictly prohibited from making a request for payment that is not immediately related to any specific loss mitigation option. Some examples of impermissible communications include initiating conversations with the borrower related to repayment of the debt that are not for the purposes of loss mitigation, demanding that the borrower make a payment, requesting that the borrower bring the account current or make a partial payment on the account, or attempting to collect the outstanding balance or arrearage, unless such communications are immediately related to a specific loss mitigation option.30 Additionally, all other provisions of the FDCPA, including the prohibitions contained in FDCPA sections 805 through 808, continue to apply.31

30See 53 FR 50097, 50103 (Dec. 13, 1988) (Section 805(c)-2 of the Federal Trade Commission's (FTC) Official Staff Commentary on FDCPA section 805(c)) (“A debt collector's response to a `cease communication' notice from a consumer may not include a demand for payment, but is limited to the three statutory exceptions [under FDCPA section 805(c)(1) through (3)].”).

31 For example, servicers that are debt collectors must not: Engage in conduct the natural consequence of which is to harass, oppress, or abuse any person in connection with the collection of a debt; use any false, deceptive, or misleading representation or means in connection with the collection of a debt; or use unfair or unconscionable means to collect or attempt to collect any debt.

III. Regulatory Requirements

This rule articulates the Bureau's interpretation of the FDCPA. It is exempt from notice and comment rulemaking requirements under the Administrative Procedure Act pursuant to 5 U.S.C. 553(b). Because no notice of proposed rulemaking is required, the Regulatory Flexibility Act does not require an initial or final regulatory flexibility analysis.32 The Bureau has determined that this rule does not impose any new or revise any existing recordkeeping, reporting, or disclosure requirements on covered entities or members of the public that would be collections of information requiring OMB approval under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

The U.S. Small Business Administration (SBA) published a final rule in the Federal Register on July 25, 2016 (81 FR 48557), amending its regulations to establish a new Government-wide mentor-protégé program for all small business concerns, consistent with SBA's mentor-protégé program for Participants in SBA's 8(a) Business Development (BD) program. The rule also made several additional changes to current size, 8(a), Office of Hearings and Appeals, and HUBZone regulations, concerning among other things, ownership and control, changes in primary industry, economic disadvantage of a Native Hawaiian Organization (NHO), standards of review, and interested party status for some appeals. This document makes several technical corrections to that final rule, including correcting citations, eliminating a paragraph that conflicts with a new provision added by that final rule, and making conforming amendments.

The final rule published on July 25, 2016, at 81 FR 48557, contained several errors, including inadvertent oversights and omissions that must be corrected in order to ensure consistency within the regulations and to avoid public uncertainty or confusion. First, a correction is needed because the amendment in instruction 5 on page 48579, column one, should have also applied to § 121.702(b)(1)(i), not just paragraph (a)(1). Specifically, the instruction should have read: “Amend §§ 121.702(a)(1)(i) and (b)(1)(i) by adding the words `an Indian tribe, ANC or NHO (or a wholly owned entity of such tribe, ANC or NHO),' before the words `or any combination of these.' ” The final rule amended the requirements for the Small Business Innovation Research (SBIR) Program to specifically recognize that a small business concern owned and controlled by an Indian tribe, Alaska Native Corporation (ANC) or a Native Hawaiian Organization (NHO) may be eligible to participate in the SBIR Program. Historically, the eligibility requirements for the SBIR Program have been consistent with those for SBA's Small Business Technology Transfer (STTR) Program. While the final rule amended the eligibility requirements for the SBIR Program in § 124.702(a)(1)(i), it inadvertently did not make the same corresponding change to the STTR Program. As such, this correction is necessary to add that same clarifying language to the STTR eligibility requirements as that added to the SBIR requirements.

Second, a correction is needed to delete § 124.110(g)(2). After this correction, a corresponding correction to the numbering also needs to occur that would eliminate paragraph (g)(1) as a separate paragraph and move the substance of paragraph (g)(1) to the end of the introductory text of paragraph (g). In response to public comment, SBA changed the way in which SBA requires an applicant concern to demonstrate the economic disadvantage status of a NHO. See § 124.110(c) (81 FR 48580-48581). Section 124.110(g)(2) had meaning only with respect to the way SBA previously required an applicant concern to demonstrate the economic disadvantage status of an NHO. SBA mistakenly did not remove § 124.110(g)(2) when it made the change to § 124.110(c). This correction is needed to remove the paragraph because it is now inconsistent with the July 25, 2016 final rule.

Third, a correction is needed to make a conforming change to § 124.112. The final rule eliminated the requirement from § 124.203 that an applicant must submit IRS Form 4506T in every case, and clarified that SBA may request additional documentation during the 8(a) application process when necessary. However, the final rule did not make the conforming change that the IRS Form 4506T is not needed in every case for an annual review as well, but, rather, may be requested on a case-by-case basis during an annual review by SBA.

Fourth, due to the change made to § 121.103(h), which eliminated the ability of a joint venture to be populated with individuals intended to perform contracts awarded to the joint venture, a conforming correction is needed to § 124.513(c), which references populated joint ventures. Specifically, § 124.513(c)(4) provided that in the case of a populated separate legal entity joint venture, 8(a) Participant(s) must receive profits from the joint venture commensurate with their ownership interests in the joint venture. Because SBA eliminated populated joint ventures, that provision is now superfluous and needs to be deleted.

Fifth, a correction is needed to amend an incorrect cross reference. The final rule revised § 126.615. That revised language referenced an exception contained in § 126.618(d). There is no paragraph (d). Therefore, the cross reference contained in § 126.615 is revised to read § 126.618.

Sixth, a correction is needed to correct a mistaken instruction. Instruction 2 on page 48578 purported to revise the last two sentences of the introductory text of 13 CFR 121.103(h). However, on May 31, 2016, SBA amended paragraph (h) by adding a new final sentence to the introductory text of paragraph (h). 81 FR 34243, 34258, instruction 2.c. Consequently, a sentence that SBA intended to remove remains in paragraph (h), while a sentence that SBA added on May 31, 2016 was revised. Thus, SBA is revising the introductory text of paragraph (h) to read as intended under both rules.

List of Subjects13 CFR Part 121

Administrative practice and procedure, Government procurement, Government property, Individuals with disabilities, Loan programs—business, Reporting and recordkeeping requirements, Small businesses.

Administrative practice and procedure, Government procurement, Penalties, Reporting and recordkeeping requirements, Small businesses.

Accordingly, 13 CFR parts 121,124, and 126 are corrected by making the following correcting amendments:

PART 121—SMALL BUSINESS SIZE REGULATIONS1. The authority citation for part 121 continues to read as follows:Authority:

15 U.S.C. 632, 634(b)(6), 662, and 694a(9).

2. Amend § 121.103 by revising the introductory text of paragraph (h) to read as follows:§ 121.103 How does SBA determine affiliation?

(h) Affiliation based on joint ventures. A joint venture is an association of individuals and/or concerns with interests in any degree or proportion consorting to engage in and carry out no more than three specific or limited-purpose business ventures for joint profit over a two year period, for which purpose they combine their efforts, property, money, skill, or knowledge, but not on a continuing or permanent basis for conducting business generally. This means that a specific joint venture entity generally may not be awarded more than three contracts over a two year period, starting from the date of the award of the first contract, without the partners to the joint venture being deemed affiliated for all purposes. Once a joint venture receives one contract, SBA will determine compliance with the three awards in two years rule for future awards as of the date of initial offer including price. As such, an individual joint venture may be awarded more than three contracts without SBA finding general affiliation between the joint venture partners where the joint venture had received two or fewer contracts as of the date it submitted one or more additional offers which thereafter result in one or more additional contract awards. The same two (or more) entities may create additional joint ventures, and each new joint venture entity may be awarded up to three contracts in accordance with this section. At some point, however, such a longstanding inter-relationship or contractual dependence between the same joint venture partners will lead to a finding of general affiliation between and among them. For purposes of this provision and in order to facilitate tracking of the number of contract awards made to a joint venture, a joint venture: Must be in writing and must do business under its own name; must be identified as a joint venture in the System for Award Management (SAM); may be in the form of a formal or informal partnership or exist as a separate limited liability company or other separate legal entity; and, if it exists as a formal separate legal entity, may not be populated with individuals intended to perform contracts awarded to the joint venture (i.e., the joint venture may have its own separate employees to perform administrative functions, but may not have its own separate employees to perform contracts awarded to the joint venture). SBA may also determine that the relationship between a prime contractor and its subcontractor is a joint venture, and that affiliation between the two exists, pursuant to paragraph (h)(5) of this section. For purposes of this paragraph (h), contract refers to prime contracts, and any subcontract in which the joint venture is treated as a similarly situated entity as the term is defined in part 125 of this chapter.

§ 121.702 [Amended]3. Amend § 121.702(b)(1)(i) by adding the words “an Indian tribe, ANC or NHO (or a wholly owned business entity of such tribe, ANC or NHO),” before the words “or any combination of these”.PART 124—8(A) BUSINESS DEVELOPMENT/SMALL DISADVANTAGED BUSINESS STATUS DETERMINATIONS3. The authority citation for part 124 continues to read as follows:Authority:

4. Amend § 124.110 by revising paragraph (g) to read as follows:§ 124.110 Do Native Hawaiian Organizations have any special rules for applying to the 8(a) BD program?

(g) An NHO-owned firm's eligibility for 8(a) BD participation is separate and distinct from the individual eligibility of the NHO's members, directors, or managers. The eligibility of an NHO-owned concern is not affected by the former 8(a) BD participation of one or more of the NHO's individual members.

§ 124.112 [Amended]5. Amend § 124.112 by adding the word “and” at the end of paragraph (b)(8), removing paragraph (b)(9), and redesignating paragraph (b)(10) as paragraph (b)(9). 6. Amend § 124.513 by revising paragraph (c)(4) to read as follows:§ 124.513 Under what circumstances can a joint venture be awarded an 8(a) contract?

(c) * * *

(4) Stating that the 8(a) Participant(s) must receive profits from the joint venture commensurate with the work performed by the 8(a) Participant(s);

PART 126—HUBZONE PROGRAM7. The authority citation for part 126 continues to read as follows:Authority:

The U.S. Small Business Administration (SBA) published a final rule in the Federal Register on July 25, 2016, (81 FR 48557) to, among other things, implement provisions of the National Defense Authorization Act of 2013, which pertain to performance requirements applicable to small business and socioeconomic program set-aside contracts and small business subcontracting. That rule contained an instruction to amend portions of § 125.6 that do not exist. This document removes the amendatory instruction.

SBA published a final rule in the Federal Register on May 31, 2016 (81 FR 34243). That rule amended § 125.6. On July 25, 2016, SBA published a separate final rule in the Federal Register (81 FR 48557) that purported to amend § 125.6 by removing “§ 125.15” from the introductory text of paragraph (b) and adding in its place “§ 125.18” and by removing “§ 125.15(b)(3)” from paragraph (b)(5) and adding in its place “§ 125.18(b)(3)”. These amendments could not be implemented as instructed because paragraph 125.6 (b) does not contain the text to be removed. These changes inadvertently failed to take into account the amendments made to § 125.6 by the final rule published on May 31, 2016. This correction removes the instruction to amend § 125.6 published on July 25, 2016, in 81 FR 48558.

In the FR Rule Doc. No. 2016-16399 in the issue of July 25, 2016, beginning on page 48557, make the following correction:

This document provides Emergency Restriction/Prohibition Order No. FAA-2016-9288, issued October 14, 2016 and effective at 12 p.m. (noon) Eastern Daylight Time (EDT), October 15, 2016 to Samsung Galaxy Note 7 Users and air carriers. The Emergency Order prohibits persons from offering for air transportation or transporting via air any Samsung Galaxy Note 7 device on their person, in carry-on baggage, in checked baggage, or as cargo; requires individuals who inadvertently bring a Samsung Galaxy Note 7 device onto an aircraft immediately power off the device, not use or charge the device while aboard the aircraft, protect the device from accidental activation, including disabling any features that may turn on the device, such as alarm clocks, and keep the device on their person and not in the overhead compartment, seat back pocket, nor in any carry-on baggage, for the duration of the flight; requires air carriers to alert passengers to the prohibition against air transport of Samsung Galaxy Note 7 devices, in particular, immediately prior to boarding, and to deny boarding to a passenger in possession of a Samsung Galaxy Note 7 device unless and until the passenger divests themselves and their baggage of the Samsung Galaxy Note 7 device; and requires that if an air carrier flight crew member identifies that a passenger is in possession of a Samsung Galaxy Note 7 device while the aircraft is in flight, the crew member must instruct the passenger to power off the device and not to use or charge the device onboard the aircraft and protect the device from accidental activation, including disabling any features that may turn on the device, such as alarm clocks, and keep the device on their person and not in the overhead compartment, seat back pocket, nor in any carry-on baggage, for the duration of the flight.

DATES:

The Emergency Restriction/Prohibition Order provided in this document is effective at 12 p.m. (noon) Eastern Daylight Time (EDT) on October 15, 2016.

The full text of Emergency Restriction/Prohibition Order No. FAA-2016-9288 issued October 14, 2016 is as follows:

This Emergency Restriction/Prohibition Order (Order) is issued by the United States Department of Transportation (DOT) pursuant to 49 U.S.C. 5121(d) and will be effective at 12:00 p.m. (noon) Eastern Daylight Time (EDT), October 15, 2016. This Order is issued to all persons who transport or offer a Samsung Galaxy Note 7 device for air transportation in commerce within the United States. Individuals who own or possess a Samsung Galaxy Note 7 device may not transport the device on their person, in carry-on baggage, in checked baggage, nor offer the device for air cargo shipment. This prohibition includes all Samsung Galaxy Note 7 devices. Samsung Galaxy Note 7 devices are properly classified as lithium ion batteries contained in equipment, UN3481, Class 9 (49 CFR 172.101).

By this Order, DOT is:

* Prohibiting persons from transporting or offering for air transportation a Samsung Galaxy Note 7 device, by either carrying it on their person or in carry-on baggage when boarding an aircraft, placing the Samsung Galaxy Note 7 device in checked baggage, or shipping it via air as cargo;

* requiring air carriers to alert passengers to the prohibition against air transport of a Samsung Galaxy Note 7 device, in particular, immediately prior to boarding and to deny boarding to a passenger in possession of a Samsung Galaxy Note 7 device unless and until the passenger divests themselves and their baggage, including carry-on and checked, of the Samsung Galaxy Note 7 device;

* requiring that persons who inadvertently bring a Samsung Galaxy Note 7 device onto an aircraft immediately power off the device, do not use or charge the device while aboard the aircraft, protect the device from accidental activation, including disabling any features that may turn on the device, such as alarm clocks, and keep the device on their person and not in the overhead compartment, seat back pocket, nor in any carry-on baggage, for the duration of the flight; and

* requiring that if an air carrier flight crew member identifies that a passenger is in possession of a Samsung Galaxy Note 7 device while the aircraft is in flight, the crew member must instruct the passenger to power off the device, do not use or charge the device while aboard the aircraft, protect the device from accidental activation, including disabling any features that may turn on the device, such as alarm clocks, and keep the device on their person and not in the overhead compartment, seat back pocket, nor in any carry-on baggage, for the duration of the flight.

Upon information derived from the Samsung Galaxy Note 7 device recall issued September 15, 2016, recent incidents of a dangerous evolution of heat with Samsung Galaxy Note 7 replacement devices, Samsung's October 11, 2016 decision to stop manufacturing and selling Samsung Galaxy Note 7 devices due to the inability to identify the root cause of the incidents, and the U.S. Consumer Product Safety Commission (CPSC) recall of all Samsung Galaxy Note 7 device issued October 13, 2016, the Secretary of Transportation (Secretary) has found an unsafe condition and that an unsafe practice exists and constitutes an imminent hazard to the safety of air transportation. For more detailed information see “Background/Basis for Order” below.

Effective at 12 p.m. (Noon) Eastern Daylight Time, October 15, 2016, Any Person Identified by This Order

(1) Shall not transport, nor offer for transportation, via air a Samsung Galaxy Note 7 device. By virtue of this Order and the CPSC recalls, the Samsung Galaxy Note 7 devices are now forbidden for transportation by air. For purposes of this Order, transporting or offering for transportation includes bringing a Samsung Galaxy Note 7 device aboard an aircraft on your person (e.g., in your pocket), bringing a Samsung Galaxy Note 7 device aboard an aircraft in carry-on baggage, offering a Samsung Galaxy Note 7 device in checked baggage, and offering a Samsung Galaxy Note 7 device for air cargo shipment (e.g., Federal Express or United Parcel Service).

(2) Shall ensure that a prohibited Samsung Galaxy Note 7 device inadvertently brought aboard an aircraft is immediately powered off, not used or charged while aboard the aircraft, protected from accidental activation, including disabling any features that may turn on the device, such as alarm clocks, and kept on their person and not in the overhead compartment, seat back pocket, nor in any carry-on baggage, for the duration of the flight.

Air Carrier Requirements

By virtue of this Order and the CPSC recalls, the Samsung Galaxy Note 7 device is a forbidden hazardous material. In accordance with 49 CFR part 175, air carriers must not accept these devices for air transportation by knowingly permitting a passenger to board an aircraft with a Samsung Galaxy Note 7 device. Damaged or recalled lithium ion batteries, including those contained in equipment, are not permitted to be transported by air, and a Samsung Galaxy Note 7 device is categorized as “forbidden.” 49 CFR 173.21(c). Air carriers are required to make passengers aware of the prohibition against transport of Samsung Galaxy Note 7 devices aboard aircraft on their person, in carry-on or checked baggage, and as air cargo. Air carriers must also alert passengers to this prohibition immediately prior to boarding. If an air carrier representative identifies that a passenger is in possession of a Samsung Galaxy Note 7 device prior to boarding the aircraft, the air carrier must deny boarding to the passenger unless and until the passenger divests themselves, including on their person and in checked and carry-on baggage, of the Samsung Galaxy Note 7 device. If an air carrier flight crew member identifies that a passenger is in possession of a Samsung Galaxy Note 7 device while the aircraft is in flight, the crew member must instruct the passenger to power off the device, not use or charge the device while aboard the aircraft, protect the device from accidental activation, including disabling any features that may turn on the device, such as alarm clocks, and keep the device on their person and not in the overhead compartment, seat back pocket, nor in any carry-on baggage, for the duration of the flight.

This Order applies to all persons who transport Samsung Galaxy Note 7 devices, or offer them for transportation, by air in commerce (as defined by 49 U.S.C. 5102(1)) to, from, and within the United States, and their officers, directors, employees, subcontractors, and agents. This Order is effective at 12 p.m. (noon) Eastern Daylight Time (EDT), October 15, 2016, and remains in effect unless rescinded in writing by the Secretary, or until it otherwise expires by operation of regulation and/or law.

Jurisdiction

The Secretary has the authority to regulate the transportation of lithium ion batteries contained in equipment in commerce. 49 U.S.C. 5103(b). The Secretary has designated lithium ion batteries contained in equipment, UN 3481, as a hazardous material subject to the requirements of the HMR. 49 U.S.C. 5103(a); 49 CFR 172.101. Persons who offer for transportation, or transport, lithium ion batteries contained in equipment by air in commerce to, from, and within the United States are a “person,” as defined by 49 U.S.C. 5102(9), in addition to being a “person” under 1 U.S.C. 1 and a “person who offers” as defined by 49 CFR 171.8. “Commerce” is as defined by 49 U.S.C. 5102(1) and 49 CFR 171.8, and “transportation” or “transport” are as defined by 49 U.S.C. 5102(13) and 49 CFR 171.8. Accordingly, persons who transport or offer for transportation lithium ion batteries contained in equipment in commerce, including by air, are subject to the authority and jurisdiction of the Secretary including the authority to impose emergency restrictions, prohibitions, recalls, or out-of-service orders, without notice or an opportunity for hearing, to the extent necessary to abate the imminent hazard. 49 U.S.C. 5121(d).

Background/Basis for Order

An imminent hazard, as defined by 49 U.S.C. 5102(5), constitutes the existence of a condition relating to hazardous materials that presents a substantial likelihood that death, serious illness, severe personal injury, or a substantial endangerment to health, property, or the environment may occur before the reasonably foreseeable completion date of a formal proceeding begun to lessen the risk that death, illness, injury or endangerment may occur.

A Samsung Galaxy Note 7 device may cause an ignition or a dangerous evolution of heat or become a fuel source for fire. Samsung and CPSC acknowledged this fact with the September 15, 2016 recall, Samsung's October 11, 2016 announcement that it was suspending the manufacture and sale of the Samsung Galaxy Note 7 device, and the October 13, 2016 Samsung and CPSC expanded recall covering all Samsung Galaxy Note 7 devices. Furthermore, persons have experienced incidents of dangerous evolution of heat with the recalled Samsung Galaxy Note 7 devices. Just one fire incident poses a high risk of death, serious illness, severe personal injury, and danger to property and the environment. This risk is magnified when the fire or evolution of heat occurs aboard an aircraft during flight. Therefore, each offering and transportation of a Samsung Galaxy Note 7 device constitutes an imminent hazard.

A. Samsung Galaxy Note 7 Recall and Incidents

On September 15, 2016, Samsung and the CPSC recalled certain Samsung Galaxy Note 7 devices sold prior to September 15, 2016. The recall was based on a finding that the lithium ion battery in a Samsung Galaxy Note 7 device “can overheat and catch fire.” Samsung offered either a refund or replacement Samsung Galaxy Note 7 device. Subsequently, there were reported incidents of the replacement Samsung Galaxy Note 7 devices overheating and/or catching fire. In a decision announced on October 11, 2016, Samsung stopped production and sale of Samsung Galaxy Note 7 devices. On October 13, 2016, Samsung and the CPSC expanded the recall to include all Samsung Galaxy Note 7 devices because they “can overheat and catch fire.”

In the wake of Samsung Galaxy Note 7 device incidents, the Federal Aviation Administration (FAA) and Pipeline and Hazardous Materials Safety Administration (PHMSA) have taken a number of steps to mitigate the safety risk of Samsung Galaxy Note 7 devices in air transportation. On September 8, 2016, the FAA issued a statement strongly advising passengers not to turn on or charge a Samsung Galaxy Note 7 device aboard an aircraft, nor stow a Samsung Galaxy Note 7 device in any checked baggage. On September 15, 2016, PHMSA issued a Safety Advisory Notice to inform the public about the risks associated with transporting damaged, defective, or recalled lithium batteries or portable electronic devices, including the Samsung Galaxy Note 7 device recalled by the CPSC. The Safety Advisory Notice required that persons who wish to carry the recalled Samsung Galaxy Note 7 device aboard an aircraft must (1) turn off the device; (2) disconnect the device from charging equipment; (3) disable all applications that could inadvertently activate the phone; protect the power switch to prevent its unintentional activation; and (4) keep the device in carry-on baggage or on your person.

On September 16, 2016, the FAA issued general guidance to airlines about the rules for carrying recalled or defective lithium batteries and lithium battery-powered devices aboard an aircraft. Specifically, the FAA noted that (1) U.S. hazardous materials regulations prohibit air cargo shipments of recalled or defective lithium batteries and lithium battery-powered devices; (2) passengers may not turn on or charge the devices when they carry them aboard the aircraft; (3) passengers must protect the devices from accidental activation; and (4) passengers must not pack them in checked baggage. On September 16, 2016, the FAA issued a Safety Alert for Operators (SAFO), recommending the following action by air operators: (1) Ensure that operator personnel responsible for cargo processing know and understand that damaged or recalled lithium batteries—including those installed in equipment and devices—are forbidden on aircraft as air cargo; and (2) ensure that operator personnel responsible for passenger processing and cabin safety know and understand that damaged or recalled lithium batteries—including those installed in devices—may be restricted from carriage or use on the aircraft. On October 10, 2016, the FAA issued updated guidance on the Samsung Galaxy Note 7 device, urging passengers aboard an aircraft to power down and not use, charge, or stow in checked baggage, any Samsung Galaxy Note 7 device.

Notwithstanding the above DOT actions, and in light of continued risks identified by Samsung and CPSC associated with Samsung Galaxy Note 7 devices, the further action described in this Order is necessary to eliminate unsafe conditions that create an imminent hazard to public health and safety and the environment.

Remedial Action

To eliminate or abate the imminent hazard:

(1) Persons covered by this Order shall not transport, nor offer for transportation, via air any Samsung Galaxy Note 7 device.

(2) Air carriers are required to alert passengers to the prohibition against air transport of Samsung Galaxy Note 7 devices, in particular, immediately prior to boarding and to deny boarding to a passenger in possession of a Samsung Galaxy Note 7 device unless and until the passenger divests themselves and carry-on or checked baggage of the Samsung Galaxy Note 7 device.

(3) Persons covered by this Order who inadvertently bring a prohibited Samsung Galaxy Note 7 device aboard an aircraft must immediately power off the device, leave it powered off until no longer aboard the aircraft, not use or charge the device while aboard the aircraft, protect the device from accidental activation, including disabling any features that may turn on the device, such as alarm clocks, and keep the device on their person and not in the overhead compartment, seat back pocket, nor in any carry-on baggage, for the duration of the flight.

(4) When a flight crew member identifies that a passenger is in possession of a Samsung Galaxy Note 7 device while the aircraft is in flight, the crew member must instruct the passenger to power off the device, not use or charge the device while aboard the aircraft, protect the device from accidental activation, including disabling any features that may turn on the device, such as alarm clocks, and keep the device on their person and not in the overhead compartment, seat back pocket, nor in any carry-on baggage, for the duration of the flight.

Rescission of This Order

This Order remains in effect until the Secretary determines that an imminent hazard no longer exists or a change in applicable statute or federal regulation occurs that supersedes the requirements of this Order, in which case the Secretary will issue a Rescission Order.

Failure To Comply

Any person failing to comply with this Order is subject to civil penalties of up to $179,933 for each violation for each day they are found to be in violation (49 U.S.C. 5123). A person violating this Order may also be subject to criminal prosecution, which may result in fines under title 18, imprisonment of up to ten years, or both (49 U.S.C. 5124).

Right To Review

Pursuant to 49 U.S.C. 5121(d)(3) and in accordance with section 554 of the Administrative Procedure Act (APA), 5 U.S.C. 500 et seq, a review of this action may be filed. Any petition seeking relief must be filed within 20 calendar days of the date of this order (49 U.S.C. 5121(d)(3)), and addressed to U.S. DOT Dockets, U.S. Department of Transportation, 1200 New Jersey Avenue SE., Room W12-140, Washington, DC 20590 (http://Regulations.gov). Furthermore, a petition for review must state the material facts at issue which the petitioner believes dispute the existence of an imminent hazard and must include all evidence and exhibits to be considered. The petition must also state the relief sought. Within 30 days from the date the petition for review is filed, the Secretary must approve or deny the relief in writing; or find that the imminent hazard continues to exist, and extend the original Emergency Order. In response to a petition for review, the Secretary may grant the requested relief in whole or in part; or may order other relief as justice may require (including the immediate assignment the case to the Office of Hearings for a formal hearing on the record).

Emergency Contact Official

If you have any questions concerning this Emergency Restriction/Prohibition Order, you should call PHMSA Hazardous Materials Information Center at 1-800-467-4922 or email at phmsa.hm-infocenter@dot.gov.

This document contains a conditional exception, pursuant to authority under the Bank Secrecy Act, which would permit certain U.S. financial institutions to maintain correspondent accounts for Burmese banks under certain conditions.

All questions about the exceptive relief must be addressed to the FinCEN Resource Center at (800) 767-2825 (Monday through Friday, 8:00 a.m.-6:00 p.m. ET).

SUPPLEMENTARY INFORMATION:

I. Statutory and Regulatory Background

The Bank Secrecy Act (“BSA”), Titles I and II of Public Law 91-508, as amended, codified at 12 U.S.C. 1829b, 12 U.S.C. 1951-1959, and 31 U.S.C. 5311-5314 and 5316-5332, authorizes the Secretary of the Treasury (“Secretary”), among other things, to issue regulations requiring persons to keep records and file reports that are determined to have a high degree of usefulness in criminal, tax, regulatory, and counter-terrorism matters. The regulations implementing the BSA appear at 31 CFR Chapter X. The Secretary's authority to administer the BSA has been delegated to the Director of FinCEN.1

1 Treasury Order 180-01 (Sept. 26, 2002).

FinCEN has the authority, under 31 U.S.C. 5318(a)(7) and 31 CFR 1010.970, to make exceptions to the requirements of 31 CFR Chapter X. Such exceptions may be conditional or unconditional, may apply to particular persons or to classes of persons, and may apply to particular transactions or classes of transactions. Moreover, an exception is issuable or revocable in the sole discretion of FinCEN, based on the circumstances to which the exception applies.

The provisions of paragraphs (b)(1) and (2) of 31 CFR 1010.651 shall not apply to a correspondent account that is established, maintained, administered, or managed in the United States by a covered financial institution (as defined in 31 CFR 1010.651(a)(3)) for, or on behalf of, a Burmese banking institution, provided that such covered financial institution subjects the account to the due diligence obligations set forth under Section 312 of the USA PATRIOT Act and its implementing regulation 31 CFR 1010.610.

FinCEN is providing this exceptive relief given (i) FinCEN's assessment of Burma's progress to date in addressing issues identified in FinCEN's 2003 finding that Burma was a jurisdiction of primary money laundering concern; (ii) a high-level commitment by Burma to continue making progress in addressing those issues; and (iii) FinCEN's consideration of the ongoing effect on U.S. national security and foreign policy of U.S. financial institutions' compliance with 31 CFR 1010.651.

Section 311 Action Against Burma

On November 18, 2003, FinCEN found Burma to be a jurisdiction of primary money laundering concern pursuant to 31 U.S.C. 5318A, as added by Section 311 of the USA PATRIOT Act of 2001 (Section 311).2 FinCEN based its finding on a number of factors, including (i) Burma's lack of an effective anti-money laundering/countering the financing of terrorism (AML/CFT) regime; (ii) high levels of public corruption in Burma; (iii) a recognition that Burma is a haven for international drug trafficking; and (iv) a lack of cooperation by Burma with U.S. law enforcement agencies in criminal matters. In connection with this finding, on April 12, 2004, FinCEN issued a final rule at 31 CFR 1010.651 prohibiting U.S. financial institutions from maintaining U.S. correspondent accounts for Burmese banking institutions.3

2 68 FR 66299 (Nov. 25, 2003).

3 69 FR 19093 (Apr. 12, 2004) (codified at 31 CFR 1010.651).

Burma's Progress in Addressing the Concerns Described in the Section 311 Finding

Since FinCEN promulgated the final rule in 2004, Burma has taken steps to improve its AML/CFT regime and to address the issues of corruption, drug trafficking, and law enforcement cooperation.

Improvements to Burma's AML/CFT Regime

FinCEN's finding noted that “the Burmese anti-money laundering law is ineffective and unenforceable” and could not be regarded as effectively remedying a number of AML/CFT deficiencies, including that: (i) The Burmese Central Bank had no anti-money laundering regulations for financial institutions; (ii) banks licensed by Burma were not legally required to obtain or maintain identification information about their customers; (iii) such banks were also not required to maintain transaction records of customer accounts; and (iv) Burmese financial institutions were not required to report suspicious transactions.4

4 68 FR at 66300.

Since 2012, Burma has made significant progress in addressing the strategic AML/CFT deficiencies identified by the Financial Action Task Force (FATF),5 which resulted in its removal in June 2016 from the FATF's public list of countries with strategic AML/CFT deficiencies. In 2013, the Burmese Central Bank, which previously had been part of the Ministry of Finance, became independent. Through its 2014 Money Laundering Law and the Burmese Central Bank's 2015 customer due diligence directive, Burma now requires financial institutions to conduct due diligence and know the true identity of their customers including beneficial owners. Burma has criminalized money laundering and terrorist financing, and it has established a legal framework to implement targeted financial sanctions under United Nations Security Council Resolutions (UNSCR) 1267, 1373, and related resolutions. Further, Burma has established a financial intelligence unit and made progress in ensuring that it has operational and budgetary independence.

5 The FATF is an inter-governmental body that sets standards and promotes effective implementation of legal, regulatory, and operational measures for combating money laundering, terrorist financing, and other related threats to the integrity of the international financial system.

Actions Addressing Public Corruption in Burma

FinCEN's finding noted that, as of 2003, Transparency International—the leading international non-governmental organization devoted to curbing corruption—ranked Burma as “the fourth most corrupt jurisdiction out of 133 jurisdictions assessed worldwide.” 6 Burma has taken some significant steps to address public corruption. In 2012, Burma ratified the UN Convention against Corruption.7 Burma passed an Anti-Corruption Law in 2013 (and amended it in 2016), improving its ability to receive and investigate allegations of official corruption.

6 68 FR at 66302.

7 United Nations Office of Drugs and Crime, Myanmar becomes the 165th State Party to UN Convention on Corruption, January 10, 2013.

Attention to International Drug Trafficking

FinCEN's 2003 finding identified Burma as “a haven for international drug trafficking” and noted that Burma had failed to take any regulatory or enforcement action against financial institutions with well-known criminal links.8 Burma is in the process of restructuring and expanding its counternarcotic task forces and Burma has worked regionally on counternarcotics initiatives, including those coordinated through the United Nations Office on Drugs and Crime.

8 68 FR at 66300-301.

Cooperation With U.S. Law Enforcement Agencies in Criminal Matters

FinCEN noted in its 2003 finding that U.S. law enforcement indicated that they rarely gained access to bank-related information pursuant to investigations, and that they received no cooperation regarding counterfeiting investigations involving Burma.9

9Id. at 66301.

U.S. law enforcement indicates that cooperation with Burmese authorities has since improved. For example, in September 2014, the U.S. and Burmese governments signed a Letter of Agreement to enhance cooperation in the fight against illicit drugs and transnational crime, and to support the development of Burma's law enforcement capacity and promote the rule of law.

FinCEN's Remaining Concerns

FinCEN is encouraged by Burma's progress thus far, but believes that Burma has not yet fully addressed the concerns articulated in the 2003 finding.

Although Burma has made a number of technical improvements to its AML/CFT regime, FinCEN remains concerned that Burma has not yet implemented its new reforms and has not displayed adequate effectiveness in mitigating the risks and threats of money laundering and terrorist financing. FinCEN also notes that a significant portion of financial activity in Burma relies upon informal money transfer systems, which remain largely unregulated and unsupervised.

FinCEN is also concerned that Burma has not sufficiently addressed the corruption issues identified in the 2003 finding. Burma's ranking on Transparency International's International Corruption Perceptions Index remains high. The U.S. State Department's 2016 International Narcotics Control Strategy Report on Burma notes that “corruption is endemic in both business and government. . . The rule of law remains weak, and Burma continues to face a significant risk of narcotics proceeds being laundered through commercial ventures.” 10

10 U.S. State Department, 2016 International Narcotics Control Strategy Report, available at http://www.state.gov/j/inl/rls/nrcrpt/2016/vol2/253387.htm.

The United States also continues to recognize Burma as a haven for international drug trafficking. In September 2016, under the Foreign Relations Authorization Act, the President determined Burma to be a major illicit drug producing country or major drug-transit country.11 Further, Burma's cooperation with U.S. law enforcement, while improved since 2003, nonetheless remains nascent and largely untested.

As noted in the final rule, the Section 311 action was designed to encourage Burma to make necessary changes to its AML/CFT regime in order to address FinCEN's concerns. Burma has begun to address those concerns, but significant work remains. FinCEN welcomes Burma's recent commitment to work with FinCEN and other components of the U.S. Department of the Treasury, as well as with the U.S. government more broadly, in advancing its AML/CFT efforts. FinCEN has considered Burma's progress, its remaining deficiencies, and its commitment to address those deficiencies in deciding to issue this exceptive relief.

This exceptive relief also takes into account the effect of FinCEN's action on U.S. national security and foreign policy, as did the final rule.12 FinCEN's final rule contained an exemption at 31 CFR 1010.651(b)(3) that allowed U.S. financial institutions to maintain correspondent accounts for Burmese banks if such activity was licensed under authorities administered by the U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC). Since 2012, OFAC has, via general licenses, authorized a broad range of financial activity with respect to Burma that would otherwise have been prohibited under the Section 311 rule. On October 7, 2016, the President terminated the national emergency with respect to Burma and revoked all Burma sanctions Executive orders, lifting the economic and financial sanctions on Burma administered by OFAC. As a result of the termination of the Burma sanctions program, the OFAC general licenses referenced above are no longer in effect. Therefore, the exemption incorporated into FinCEN's final rule at 31 CFR 1010.651(b)(3), which effectively permitted U.S. correspondent account activity with Burmese banks, no longer has any operational effect. FinCEN has taken this into consideration in deciding to issue this exceptive relief.

The Environmental Protection Agency (EPA) is finalizing approval and finalizing the conditional approval of portions of the fine particulate matter (PM2.5) State Implementation Plan (SIP) and other general rule revisions submitted by the State of Utah. The revisions affect the Utah Division of Administrative Rules (DAR), R307-300 Series; Requirements for Specific Locations. The revisions had submission dates of May 9, 2013, May 20, 2014, September 8, 2015, and March 8, 2016. The March 8, 2016 submittal contains rule revisions to address our February 25, 2016 conditional approval of several Utah DAR R307-300 Series rules submitted on February 2, 2012, May 9, 2013, and May 20, 2014. These area source rules control emissions of direct PM2.5 and PM2.5 precursors, which are sulfur dioxides (SO2), nitrogen oxides (NOX) and volatile organic compounds (VOC). Additionally, the EPA is finalizing to approve the State's reasonably available control measure (RACM) determinations for the rule revisions that pertain to the PM2.5 SIP. This action is being taken under section 110 of the Clean Air Act (CAA or Act).

DATES:

This final rule is effective on November 18, 2016.

ADDRESSES:

The EPA has established a docket for this action under Docket ID No. EPA-R08-OAR-2016-0311. All documents in the docket are listed on the http://www.regulations.gov Web site. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available through http://www.regulations.gov, or please contact the person identified in the FOR FURTHER INFORMATION CONTACT section for additional availability information.

On October 17, 2006 (71 FR 61144), the EPA strengthened the level of the 24-hour PM2.5 National Ambient Air Quality Standards (NAAQS), lowering the primary and secondary standards from 65 micrograms per cubic meter (µg/m3), the 1997 standard, to 35 µg/m3. On November 13, 2009 (74 FR 58688), the EPA designated three nonattainment areas in Utah for the 24-hour PM2.5 NAAQS of 35 µg/m3. These are the Salt Lake City, Utah; Provo, Utah; and Logan, Utah-Idaho nonattainment areas. The State of Utah has made a number of SIP submittals intended to address the requirements under part D of title I of the CAA for these PM2.5 nonattainment areas. Among those requirements are those in sections 172(c)(1) and 189(a)(1)(C) regarding RACM and reasonably available control technology (RACT).

On August 18, 2016 (81 FR 55156), the EPA proposed to approve and conditionally approve a number of RACM components in the PM2.5 Moderate area SIP submitted by the State. Our proposed notice provides details on the EPA's interpretation of the RACM requirements under part D and our evaluation of the State's submittals. The submittals dated May 9, 2013, May 20, 2014, September 8, 2015, and March 8, 2016, contained various revisions to the Utah DAR, Title R307—Environmental Quality, set of rules, most of which are applicable to the Utah SIP for PM2.5 nonattainment areas. The rules we are addressing in this final rule were provided by Utah in the four different submissions listed above, and these rules are R307-101-2, General Requirements: Definitions; R307-302, Solid Fuel Burning Devices in Box Elder, Cache, Davis, Salt Lake, Tooele, Utah, and Weber Counties; R307-312, Aggregate Processing Operations for PM2.5 Nonattainment Areas; and R307-328, Gasoline Transfer and Storage.

II. Response to Comments

The EPA did not receive any comments on the proposed action.

III. Final Action

For the reasons stated in our proposed notice, the EPA is finalizing approval of revisions to Administrative Rule R307-101-2, along with revisions in R307-300 Series; Requirements for Specific Locations (Within Nonattainment and Maintenance Areas), R307-312 and R307-328 for incorporation into the Utah SIP as submitted by the State of Utah on March 8, 2016. This final rule completes the February 25, 2016 (81 FR 9343) conditional approval for R307-101-2, R307-312, and R307-328 that had submission dates of February 2, 2012, May 9, 2013, and May 20, 2014. Additionally, we are finalizing approval of Utah's determination that R307-312 constitutes RACM for the Utah PM2.5 SIP that was conditionally approved on February 25, 2016 (81 FR 9343); however, we are not acting at this time to determine that Utah's PM2.5 attainment plan has met all requirements regarding RACM under subparts 1 and 4 of part D, title I of the Act. We intend to act separately on the remainder of Utah's PM2.5 attainment plan.

The EPA is finalizing the conditional approval of revisions for R307-302 found in the May 9, 2013, May 20, 2014, and September 8, 2015 submittals. Additionally, the EPA is finalizing the conditional approval of Utah's determination that R307-302 constitutes RACM for the Utah PM2.5 SIP for solid fuel burning devices. As stated earlier, we are not determining that Utah's PM2.5 attainment plan has met all requirements regarding RACM under subparts 1 and 4 of part D, title I of the Act. Under section 110(k)(4) of the Act, the EPA may approve a SIP revision based on a commitment by the state to adopt specific enforceable measures by a date certain, but not later than one year after the date of approval of the plan revision. On May 19, 2016, Utah submitted a commitment letter to adopt and submit specific revisions within one year of our final action on these submittals; specifically to add continuous controls that extend to startup, shutdown, and malfunction, by establishing a prohibition on fuel types that can't be burned in a solid fuel burning device at any time. Since we are finalizing our conditional approval, Utah must adopt and submit the specific revisions it has committed to within one year of our finalization. If Utah does not submit these revisions within one year, or if we find Utah's revisions to be incomplete, or we disapprove Utah's revisions, this conditional approval will convert to a disapproval. If any of these convert to a disapproval, that will constitute a disapproval of a required plan element under part D of title I of the Act, which starts an 18-month clock for sanctions, see CAA section 179(a)(2), and the two-year clock for a federal implementation plan (FIP) to address the disapproved plan element, see CAA section 110(c)(1)(B).

IV. Incorporation by Reference

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of Utah Division of Administrative Rules described in the amendments set forth to 40 CFR part 52 below. Therefore, these materials have been approved by the EPA for inclusion in the state implementation plan, have been incorporated by reference by the EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of the EPA's approval, and will be incorporated by reference by the Director of the Federal Register in the next update to the SIP compilation.1 The EPA has made, and will continue to make, these materials generally available through www.regulations.gov and/or at the EPA Region 8 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

1 62 FR 27968 (May 22, 1997).

V. Statutory and Executive Order Reviews

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves of state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this final action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 19, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS1. The authority citation for part 52 continues to read as follows:Authority:

42 U.S.C. 7401 et seq.

Subpart TT—Utah2. Section 52.2320, the table in paragraph (c) is amended as follows:a. Under “R307-101. General Requirements” by revising the entry for “R307-101-2”;b. Under “R307-302. Davis, Salt Lake, and Utah Counties: Residential Fireplaces and Stoves” by revising the entries “R307-302-1”, “R307-302-2”, “R307-302-3”, “R307-302-4”;c. Under “R307-302. Davis, Salt Lake, and Utah Counties: Residential Fireplaces and Stoves” by adding the entries “R307-302-05”, “R307-302-06”;d. Under “R307-312. Aggregate Processing Operations for PM2.5; Nonattainment Areas” by revising the entry for “R307-312”;e. Under “R307-312. Aggregate Processing Operations for PM2.5; Nonattainment Areas” by removing the entry for “R307-312-5(2)(a)”;f. Under “R307-328. Ozone Nonattainment and Maintenance Areas and Utah and Weber Counties: Gasoline Transfer and Storage” by revising the entry for “R307-328”; andg. Under “R307-328. Ozone Nonattainment and Maintenance Areas and Utah and Weber Counties: Gasoline Transfer and Storage” by removing the entry for “307-328-4(6)”.

The Environmental Protection Agency (EPA) is taking final action on portions of six submissions from the State of Utah that are intended to demonstrate that the State Implementation Plan (SIP) meets certain interstate transport requirements of the Clean Air Act (Act or CAA). These submissions address the 2006 and 2012 fine particulate matter (PM2.5) National Ambient Air Quality Standards (NAAQS), 2008 ozone NAAQS, 2008 lead (Pb) NAAQS, 2010 sulfur dioxide (SO2) NAAQS and 2010 nitrogen dioxide (NO2) NAAQS. The interstate transport requirements under the CAA consist of four elements: Significant contribution to nonattainment (prong 1) and interference with maintenance (prong 2) of the NAAQS in other states; and interference with measures required to be included in the plan for other states to prevent significant deterioration of air quality (prong 3) or to protect visibility (prong 4). Specifically, the EPA is approving interstate transport prongs 1, 2 and 4 for the 2008 Pb NAAQS, approving prong 4 for the 2010 SO2 NAAQS, disapproving prong 4 for the 2006 PM2.5, 2008 ozone, 2010 NO2 and 2012 PM2.5 NAAQS, and disapproving prong 2 for the 2008 ozone NAAQS.

DATES:

This final rule is effective on November 18, 2016.

ADDRESSES:

EPA has established a docket for this action under Docket Identification Number EPA-R08-OAR-2016-0107. All documents in the docket are listed on the http://www.regulations.gov index. Although listed in the index, some information may not be publicly available, e.g., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically through http://www.regulations.gov or in hard copy at the Air Program, Environmental Protection Agency (EPA), Region 8, 1595 Wynkoop Street, Denver, Colorado 80202-1129. The EPA requests that you contact the individual listed in the FOR FURTHER INFORMATION CONTACT section to view the hard copy of the docket. You may view the hard copy of the docket Monday through Friday, 8:00 a.m. to 4:00 p.m., excluding federal holidays.

On May 10, 2016, the EPA proposed action on two submittals from Utah for the interstate transport requirements of CAA section 110(a)(2)(D)(i)(I) for the 2008 Pb and 2008 ozone NAAQS. 81 FR 28807. An explanation of the CAA requirements, a detailed analysis of the state's submittals, and the EPA's rationale for approval of a portion of the 2008 Pb submittal and disapproval of a portion of the 2008 ozone submittal were all provided in the notice of proposed rulemaking, and will not be restated here. The public comment period for this proposed rule ended on June 9, 2016. The EPA received four comments on the proposal, which will be addressed in the “Response to Comments” section, below.

In the May 10, 2016 proposed action, the EPA proposed to disapprove the Utah SIP for prongs 1 and 2 of CAA section 110(a)(2)(D)(i)(I) for the 2008 ozone NAAQS. In that document, the EPA cited to air quality modeling conducted to support the promulgation of an update to the Cross-State Air Pollution Rule to address interstate transport with respect to the 2008 ozone NAAQS (CSAPR Update). The air quality modeling (1) identified locations in the U.S. where the EPA anticipates nonattainment or maintenance issues in 2017 for the 2008 ozone NAAQS (these are identified as nonattainment and maintenance receptors), and (2) quantified the projected contributions from emissions from upwind states to downwind ozone concentrations at the nonattainment and maintenance receptors in 2017. The document also proposed to apply an air quality threshold of one percent of the NAAQS, equivalent to 0.75 ppb with respect to the 2008 ozone NAAQS, to determine whether a state was “linked” to an identified downwind air quality problem in another state such that the upwind state may significantly contribute to nonattainment or interfere with maintenance of the NAAQS in the downwind state. The proposal modeling data showed that emissions from Utah contribute above the one percent threshold to two identified maintenance receptors and one nonattainment receptor in the Denver, Colorado area. Accordingly, as the Utah Department of Environmental Quality (UDEQ) did not provide technical analysis to support the State's conclusion that emissions originating in Utah do not significantly contribute to nonattainment or interfere with maintenance of the 2008 ozone NAAQS in any other state, the EPA proposed to disapprove the Utah SIP as to prongs 1 and 2 of CAA section 110(a)(2)(D)(i)(I).

On September 7, 2016, the EPA promulgated a final CSAPR Update, which included updated modeling data that reflected responses to comments received in the context of the CSAPR Update rulemaking.1 The updated modeling projects three maintenance receptors in the Denver, Colorado area, but it does not project any nonattainment receptors in that area. Table 1 summarizes the air quality modeling results from the updated modeling conducted to support the final CSAPR Update relative to Utah. The modeling continues to indicate that Utah contributes emissions above the one percent threshold of 0.75 ppb with respect to 3 maintenance receptors in the Denver, Colorado area, confirming the data cited at proposal.

1 A pre-publication version of the final CSAPR Update rulemaking can be found in the docket for this action, and is available at https://www3.epa.gov/airmarkets/CSAPRU/Cross-State%20Air%20Pollution%20Rule%20Update%20for%20the%202008%20Ozone%20NAAQS%202060%20AS05%20FRM.pdf (Federal Register publication pending).

Since the updated modeling continues to indicate that the contributions from Utah are above the one percent threshold of 0.75 ppb with respect to maintenance receptors in the Denver, Colorado area, and because the State has not otherwise provided a technical analysis which demonstrates that its SIP contains adequate provisions prohibiting emissions that will interfere with maintenance of the 2008 ozone NAAQS in any other state, the EPA is finalizing a disapproval of the Utah SIP with respect to the prong 2 requirements of CAA section 110(a)(2)(D)(i)(I) as to the 2008 ozone NAAQS.

Based on this new technical information showing that there are no longer any projected 2017 nonattainment receptors in the Denver, Colorado area or any other state to which Utah contributes at or above the one percent threshold, the EPA is not finalizing the proposed disapproval with respect to prong 1 of CAA section 110(a)(2)(D)(i)(I) as to the 2008 ozone NAAQS, as the proposed disapproval was based on in part on the EPA's August 4, 2015 Notice of Data Availability (NODA) modeling of a projected nonattainment receptor in Denver, Colorado. 80 FR 46271. The EPA will address the prong 1 requirements in a separate, subsequent rulemaking.

On August 1, 2016, the EPA proposed action on six submittals from Utah for the visibility-related interstate transport requirements of CAA section 110(a)(2)(D)(i)(II) prong 4. 81 FR 50430. An explanation of the CAA requirements, a detailed analysis of the state's submittals, and the EPA's rationale for approval of portions of the 2008 Pb and 2010 SO2 submittals and disapproval of portions of the 2006 and 2012 PM2.5, 2008 ozone and 2010 NO2 submittals were all provided in the notice of proposed rulemaking, and will not be restated here. The public comment period for this proposed rule ended on August 31, 2016. The EPA did not receive any comments on this proposed action.

II. Response to Comments

Comment: Commenters UDEQ and the Wyoming Department of Environmental Quality (WDEQ) asserted that the CSAPR Update rulemaking was developed and promulgated for eastern states, and should not apply to western states. UDEQ stated that the EPA acknowledged in the CSAPR Update proposal that it will address contribution levels of western states like Utah on a case-by-case basis. 80 FR 75706, 75708 through 75709, December 3, 2015. The commenters contend that the EPA should consider other factors beyond those considered in developing the CSAPR Update.

UDEQ asserted that there are higher naturally occurring levels of background ozone in the west,2 specifically citing the EPA's draft Regulatory Impact Analysis for the proposed 2015 ozone NAAQS rulemaking, contending that “background ozone is a relatively large percentage (e.g. 70-80%) of the total seasonal mean ozone in locations in the intermountain western United States.” 3 The commenter contends that background ozone levels in Utah and Colorado must be taken into consideration when evaluating nonattainment areas within the state borders and the impact that they have on intermountain downwind states.

3 EPA's draft Regulatory Impact Analysis of the Proposed Revisions to the National Ambient Air Quality Standards for Ozone p. 2-16.

Commenter WDEQ stated that the CSAPR modeling does not adequately account for important regional differences between the east and the west, including the unique topography, altitude, weather and wildfire prevalence (including intensity and duration) in the western U.S. The commenter asserted that the EPA did not provide a technical explanation for how the model accounts for the differences between the eastern and western U.S. with regard to these factors, and that such an analysis should be conducted before the CSAPR modeling is applied to evaluate interstate transport with respect to western states. The commenter recommended that the EPA work with western states to “make regional adjustments and remove erroneous data from the CSAPR model.”

Response: The commenter does not provide any evidence or technical basis for their claim about the inadequacies of the CSAPR Update modeling for the western U.S. As described in the CSAPR Update Air Quality Modeling Technical Support Document (AQM TSD), the CSAPR modeling was performed for a nationwide domain that accounted for the differences in emissions (including actual wild fires), meteorology, and topography in various regions across the U.S. The AQM TSD includes an evaluation of 2011 base year model performance for 8-hour daily maximum concentrations on a regional and statewide basis as well as for individual monitoring sites. For example, the performance evaluation results for the region that includes Utah and Colorado indicate a mean bias of less than 10 percent for 8-hour daily maximum predicted ozone concentrations compared to the corresponding measured data. As described more fully in the AQM TSD, the EPA's use of the CAMx source apportionment modeling for the CSAPR Update is appropriate and the Agency finds its use sufficient for the purposes of assessing and identifying downwind air quality problems and contributions from upwind states in both the eastern and the western U.S. 4 The emissions modeling TSD for the CSAPR Update final rule “Preparation of Emission Inventories for the version 6.3, 2011 Emissions Modeling Platform” describes how fire emissions were developed and modeled using a consistent approach for the contiguous U.S. As described earlier, the most updated modeling continues to indicate that emissions from Utah will interfere with maintenance of the 2008 ozone NAAQS at three receptors in the Denver, Colorado area.

4 “The EPA used CAMx photochemical source apportionment modeling to quantify the impact of emissions in specific upwind states on downwind nonattainment and maintenance receptors for 8-hour ozone. CAMx employs enhanced source apportionment techniques that track the formation and transport of ozone from specific emissions sources and calculates the contribution of sources and precursors to ozone for individual receptor locations. The strength of the photochemical model source apportionment technique is that all modeled ozone at a given receptor location in the modeling domain is tracked back to specific sources of emissions and boundary conditions to fully characterize culpable sources.” 80 FR 75726, December 3, 2015.

The EPA does not find the information provided by the commenters to indicate flaws in the modeling conducted by the EPA. Rather, the commenters point to factors which the CSAPR Update modeling specifically took into account. For these reasons, the EPA disagrees with these comments and finds the use of the CSAPR Update modeling to evaluate Utah's contributions to interstate transport is reasonable and supported.

The EPA did acknowledge in the proposed CSAPR Update that “there may be additional criteria to evaluate regarding collective contribution of transported air pollution in the West,” and that “timeframe constrains the opportunity to conduct evaluations of additional criteria” in the context of that rulemaking. 80 FR 75709, December 3, 2015. The commenters do not explain how the EPA's modeling has allegedly failed to consider the other factors that they contend should be taken into account. With respect to background concentrations, UDEQ has not explained how it believes the EPA must consider background ozone levels in evaluating interstate transport in the west, nor has UDEQ cited any specific provision of the statute that specifically requires such consideration. While the EPA does not view the obligation under the good neighbor provision as a requirement for upwind states to bear all of the burden for resolving downwind air quality problems, both upwind and downwind states can take reasonable steps to control emissions impacting downwind air quality even in areas affected by high levels of background concentrations of ozone. Were the EPA to absolve upwind states of the responsibility to make such reasonable reductions, the area's citizens would suffer the health and environmental consequences of such inaction.

Notably, in its comment letter, UDEQ agreed that a further technical analysis was necessary to demonstrate that the state had satisfied prongs 1 and 2 of CAA section 110(a)(2)(D)(i)(I), and the State is in the process of developing such an analysis. The EPA will review that additional analysis when it is submitted to the EPA in a subsequent SIP submission.

Comment: Commenter Utility Air Regulatory Group (UARG) cites to EPA's action to approve Arizona's SIP in spite of the CSAPR Update modeling indicating that the state significantly contributed to nonattainment at two California receptors. The commenter contends that the EPA's differing actions on the Utah and Arizona SIPs amount to developing policy about what transport criteria apply in western states. The commenter asserted that the EPA's actions on these two SIPs establish regulatory policy in a piecemeal fashion through separate, case-by-case rulemakings, and that this practice leads to confusion and uncertainty among state officials, the public, and the regulated community. The commenter stated that the EPA should describe the western transport criteria in a comprehensive rulemaking which includes a rationale for selecting these criteria. The commenter asserted that the EPA's failure to do so would deprived interested parties of an opportunity to provide meaningful and comprehensive comments on this issue.

Response: As described in the proposal for this action and in the CSAPR Update, the EPA is assessing each of the western states transport obligations on a case-by-case basis using the information available, which includes information from the CSAPR Update modeling. The rulemaking addressing the Arizona SIP explains, as the commenter notes, why additional factors are relevant to evaluating Arizona's contribution to other states, factors that are not similarly applicable to Utah's contribution to the Denver receptors. Nothing in section 110(a)(2)(D)(i)(I) requires the EPA to establish criteria for evaluating individual SIPs through a national rulemaking. See EPA v. EME Homer City Generation, L.P., 134 S.Ct. 1584, 1601 (2014) (“nothing in the statute places EPA under an obligation to provide specific metrics to States before they undertake to fulfill their good neighbor obligation”). As required by the CAA and Administrative Procedures Act, the EPA clearly described its bases for disapproving the Utah SIP in its proposal. Similarly, the EPA also described its bases for approving the Arizona SIP in its proposal for that action. The public, including the commenter, had an opportunity to provide meaningful and comprehensive comments both on the Utah and Arizona actions, and therefore the EPA disagrees that interested parties are deprived of an opportunity to comment on issues relating to the EPA's analysis of western transport.

Comment: Commenter WDEQ stated that the EPA did not provide an explanation as to what technical analysis from the State of Utah would have been sufficient. Another commenter (UARG), quoting language from the CSAPR Update proposal (80 FR 75715, December 3, 2015), stated that EPA should identify and explain the additional criteria that may be relevant to the western states and whether it is necessary and appropriate to also evaluate the same criteria with respect to eastern states. The commenter asserted that the EPA's failure to address this issue denied the public a meaningful opportunity to comment on it.

Response: The Supreme Court has made clear that “nothing in the statute places EPA under an obligation to provide specific metrics to States before they undertake to fulfill their good neighbor obligation.” EPA v. EME Homer City Generation, 134 S.Ct. at 1601. Thus, the EPA does not agree that it is required to identify all relevant criteria for evaluating SIPs before taking formal action on the submissions. The Court explained that “[t]he statute speaks without reservation: Once a NAAQS has issued, a state `shall' propose a SIP within three years, [40 U.S.C.] 7410(a)(1), and that SIP `shall' include, among other components, provisions adequate to satisfy the Good Neighbor Provision, [40 U.S.C.] 7410(a)(2).” Id. It is therefore the responsibility of the state to demonstrate that its SIP contains provisions sufficient to meet the requirements of CAA section 110(a)(2)(D)(i)(I). A state can and should submit all of the technical information it considers relevant to evaluate its contribution to downwind air quality, including anticipated changes in the emissions from sources within the state and any additional factors specific to the state that influence its emissions and air pollution which may transport to other states. As we noted at proposal and in this final action, Utah has not submitted technical information or analysis which leads the EPA to conclude that the state is not interfering with maintenance of the NAAQS in other states, particularly in light of air quality modeling demonstrating that emissions from Utah impact air quality in Denver, Colorado. The basis for this conclusion was clearly explained at proposal, and the EPA therefore does not agree that the public did not have a meaningful opportunity to comment on the factors relevant to the proposed disapproval of the Utah SIP submission.

Comments regarding the factors relevant to evaluation of interstate transport with respect to eastern states are out of the scope of this rulemaking and do not require a response.

Comment: Commenter UDEQ stated that Utah's contributions to Denver are modest and other factors weigh against the conclusion of significant contribution or interference with maintenance. UDEQ argued that the one percent threshold should be a screening threshold that can be overcome by empirical evidence. The commenter cited a proposed EPA action on Idaho's SIP in which EPA Region 10 did not rely solely on Idaho's contribution being below one percent in its action on that SIP, but also considered Idaho's modeling data and analysis that reinforced the EPA modeling results. 80 FR 66862, October 30, 2015. UDEQ argued that the EPA should follow this and “consider additional factors when evaluating Utah's ozone infrastructure SIP.” Commenter WDEQ claimed that it is appropriate for western states to use a “weight of evidence” approach, as was used in EPA Region 9's proposed action on Arizona's 2008 ozone transport SIP. 81 FR 15200, March 22, 2016.

Response: The EPA encourages states to submit any relevant information, such as that submitted by Idaho, to assist us in evaluating a state's impact on downwind state's air quality and the control requirements in order to determine whether a state's SIP is approvable. The EPA agrees that it is appropriate to analyze all information for western states and make a conclusion based on a weight of the evidence, but the EPA has not received any such evidence from UDEQ that is sufficient to alter our determination that Utah interferes with maintenance at Denver area receptors.

The EPA notes that the one percent threshold as used in the CSAPR rulemakings is in fact a screening threshold. States are not determined to significantly contribute to nonattainment or interfere with maintenance downwind merely because emissions from the state exceed the one percent threshold. Rather, the threshold is used to identify those states that are subject to further analysis to determine whether cost-effective reductions are achievable from sources within the states. The levels of such reductions quantify the amounts of emissions that significantly contribute to nonattainment and interfere with maintenance in other states. CSAPR Update, Final Rule, pre-publication draft at 77-80. If UDEQ believes that the EPA should consider additional factors with respect to its linkage to the Denver receptors, it should identify those factors in its SIP submission. But as noted, UDEQ did not provide any technical analysis in its SIP submission, and to the extent additional factors have been identified in UDEQ's comments, it did not explain how those factors should affect the EPA's conclusion in this action. Without explaining how such factors should impact EPA's analysis, the EPA does not agree that Utah's impacts on the Denver receptors are modest, particularly considering emissions from the State contribute as much as twice the one percent air quality threshold, nor has the State offered any analysis to support this conclusory statement.

The EPA also analyzed the State's submission and in the proposal described deficiencies such as a lack of quantification of the included emission reduction measures or evaluation of how such measures are sufficient to address the State's contribution to nonattainment and maintenance receptors in Denver, Colorado. The commenters here again provide no information as to why the EPA's case-specific analysis of Utah's SIP is incorrect.

Comment: Commenter UDEQ asserted that the one percent screening threshold is arbitrary, stating that EPA only explains why it rejected five percent and anything below one percent, but does not justify one percent as opposed to two percent, which Utah meets. UDEQ argued that this threshold has not been subject to sufficient scrutiny and comment when applied to western states, and that the EPA has only determined that the one percent threshold is appropriate for eastern states. 80 FR 66862-66863, October 30, 2015.

Response: As stated in the May 10, 2016 proposal for this final action, the EPA believes contribution from an individual state equal to or above one percent of the NAAQS could be considered significant where the collective contribution of emissions from one or more upwind states is responsible for a considerable portion of the downwind air quality problem. The EPA's analysis has shown that the one percent threshold captures a high percentage of the total pollution transport affecting downwind states. 81 FR 28810, May 10, 2016. This threshold has been used by the EPA in past transport actions including the original CSAPR (76 FR 48208, August 8, 2011), and the EPA determined this threshold was appropriate following the public comment process in those previous rulemakings.

In the final CSAPR Update rulemaking, the EPA compiled the contribution modeling results from the air quality modeling in order to analyze the impact of different possible thresholds, and concluded that the one percent threshold continues to be a reasonable means of accounting for the combined impact of relatively small contributions from many upwind states. See CSAPR Update, Final Rule, pre-publication draft at 81-82; AQM TSD. For each of the ozone receptors identified in the final CSAPR Update rule analysis, the EPA identified: (1) The total upwind state contributions, and (2) the amount of the total upwind state contribution that is captured at one percent, five percent, and half (0.5) percent of the NAAQS. The EPA continues to find that the total collective contribution from upwind states' sources represent a significant portion of the ozone concentrations at downwind nonattainment and maintenance receptor locations. This analysis shows that the one percent threshold generally captures a substantial percentage of the total pollution transport affecting downwind states without also implicating states that contribute insignificant amounts. Analysis of the data for the Denver receptors at issue in this rulemaking results in the same conclusion. Use of a higher threshold would result in a relatively large reduction in the overall percentage of ozone pollution transport captured relative to the amounts captured at the one percent level at the receptors. For example, none of the transport from upwind states would be captured with a five percent threshold.

Although UDEQ proposes that the EPA should instead use a two percent threshold with respect to the Denver receptors, it has not submitted additional information or analysis to assist the EPA in determining whether there is an appropriate alternative contribution threshold for Utah or western states generally. Rather, UDEQ's proposal to use a two percent threshold appears to only be justified by the conclusion that Utah would not have been linked to Denver receptors at this level (the updated modeling indicates contribution to a maintenance receptor above two percent: See Table 1 of this preamble). Given the lack of relevant information or analysis submitted by the State, and based on an analysis of EPA's own CAMx air quality modeling data, the EPA continues to find that the one percent threshold is appropriate to apply to identify upwind states linked to the Denver receptors.

Comment: Commenter UDEQ asserted that the IPM model used to project emissions for electric generating units is not precise. The commenter supported this assertion by citing a comment from Louisiana Chemical Association (LCA) on the NODA which stated the IPM model “is simply not accurate enough and is dependent upon too many uncertain assumptions and imprecise inputs to make binding decisions of `significant contribution' or `interference with maintenance' when dealing with projections of ozone at part per billion level.” UDEQ argued that this model is imprecise and should therefore be subject to “opportunity for rebuttal based on empirical evidence.”

Response: The EPA has addressed LCA's comment in the response to comments document on the CSAPR Update proposal. In that document, we noted that the D.C. Circuit Court has recognized the usefulness of models despite the inherent uncertainty. In upholding the EPA's approach to evaluating interstate transport in CSAPR, the D.C. Circuit held that they would not “invalidate EPA's predictions solely because there might be discrepancies between those predictions and the real world. That possibility is inherent in the enterprise of prediction.” EME Homer City Generation, L.P. v. EPA, 795 F.3d 118, 135 (2015). The court continued to note that “the fact that a `model does not fit every application perfectly is no criticism; a model is meant to simplify reality in order to make it tractable.' ” Id. at 135-36 (quoting Chemical Manufacturers Association v. EPA, 28 F.3d 1259, 1264 (D.C. Cir. 1994).

The EPA has also provided thorough explanation as to how the modeling conducted for the CSAPR Update was appropriate. As stated in the final CSAPR Update, “the EPA projected future 2017 baseline EGU emissions using version 5.15 of the Integrated Planning Model (IPM) (www.epa.gov/airmarkets/power-sector-modeling). IPM, developed by ICF Consulting, is a state-of-the-art, peer-reviewed, multiregional, dynamic, deterministic linear programming model of the contiguous U.S. electric power sector. . . The model is designed to reflect electricity markets as accurately as possible. The EPA uses the best available information from utilities, industry experts, gas and coal market experts, financial institutions, and government statistics as the basis for the detailed power sector modeling in IPM.” 5 CSAPR Update, Final Rule, pre-publication draft at 131.

5 Detailed information and documentation of the EPA's Base Case, including all the underlying assumptions, data sources, and architecture parameters can be found on the EPA's Web site at: www.epa.gov/airmarkets/power-sector-modeling.

We have not received empirical evidence from the State to rebut our conclusions as stated in the proposal for this final rulemaking.

Comment: Commenter UDEQ argued that the EPA's reliance on IPM modeling is incorrect in Utah's case because this modeling used a 2011 emissions inventory that excluded certain enforceable reductions and included Carbon plant emissions, though the facility is no longer in operation.

Response: The EPA disagrees that the IPM modeling excluded certain enforceable reductions and included Carbon plant emissions. The shutdown of the Carbon power plant was accounted for in the CSAPR Update modeling, and no emissions were modeled from the facility in the 2017 scenario. (See documents and EPA-HQ-OAR-2015-0500-0205 and EPA-HQ-OAR-2015-0500-0014 in the docket for the CSAPR Update, or in the docket for this rulemaking. These documents, respectively, are the NEEDS database which defines the starting fleet in IPM and a unit level comparison of emissions from point sources between the 2011 and 2017 inventories). As for the other enforceable reductions referenced by the commenter, we cannot respond because the commenter has not provided specific detail as to the reductions that were unaccounted for. The EPA has encouraged and given the opportunity for states to submit information with regard to any inconsistencies between “on the books” upcoming reductions and the emissions modeled for the CSAPR Update in both that proposed rulemaking and in the August 4, 2015 NODA. 80 FR 46271, August 4, 2015.

Comment: Commenter UDEQ asserted that western states do not have confidence in the way in which they can submit data for consideration under the Exceptional Events Rule, which has not yet been finalized. UDEQ stated that “it will be difficult for the EPA to get an accurate assessment of the responsibility that Utah and other western states have to downwind states with regard to the 2008 ozone NAAQS as used in CSAPR until the EPA releases a final rule on these revisions.” Commenter insisted that finalization of this rulemaking will allow the EPA to address data influenced by wildfires, stratospheric intrusions, and abnormally high background ozone.

Response: The EPA agrees that the final Exceptional Events Rule will assist states and the EPA in preparing and processing exceptional events demonstrations for events, including wildfires, which contribute to monitored ozone NAAQS exceedances or violations, if those events meet the applicable criteria in the Exceptional Events Rule, including (1) the event affected air quality; (2) the event was not reasonably controllable or preventable; and (3) the event was caused by human activity that is unlikely to recur at a particular location or was a natural event. Exceptional Events Final Rule, pre-publication draft.6 Although the rule is intended to streamline the exceptional events demonstration process, there is an exceptional events rule and process currently in place. See 40 CFR 50.14. We have not received and failed to act on exceptional events demonstrations from states that would impact the determination that Utah interferes with maintenance at receptors in the Denver area.

6 See “Treatment of Data Influenced by Exceptional Events,” final rule, pre-publication draft as signed by EPA Administrator Gina McCarthy on September 16, 2016.

The EPA disagrees with the comment's note that abnormally high background ozone itself may qualify as an exceptional event. An exceptional event must be defined by the source of its emissions. If the underlying source is a natural event (e.g., wildfire) and the emissions influence a regulatory monitor, then it can be considered for exclusion under the Exceptional Events Rule. If the underlying source is anthropogenic then the explicit text of CAA section 319 requires that it can only be considered under the Exceptional Events Rule if the activity causing emissions is unlikely to recur at a particular location. The meteorological processes that result in pollutant transport and the formation of background ozone are ongoing and thus not an event, even though their influence on ambient concentrations at a particular time and location may be observed only occasionally and thus seem “event-like.” Regardless of where the activity or event that caused emissions occurred, and regardless of whether the emissions travel internationally or interstate, all exceptional event criteria applicable to that activity or event must be met in order for the emissions to be excluded.

Comment: Commenter WDEQ stated that the EPA's application of CSAPR to the western U.S. will place an undue burden on all western states. WDEQ noted that its department lacks staff experienced in running Comprehensive Air Quality Model with Extensions (CAMx version 6.11) modeling, and asserted that the EPA has acknowledged that this modeling is quite costly and resource intensive.

Response: States are not required to conduct modeling to address their interstate transport requirements under CAA section 110(a)(2)(D)(i)(I). However, where the EPA has conducted modeling that indicates emissions from a state may impact air quality in another state, both the EPA and the state must address how that modeling impacts any conclusion regarding the upwind state's compliance with the statutory interstate transport requirements. The EPA understands that air quality modeling can be both complex and resource intensive, and remains committed to assisting the states in conducting or reviewing air quality modeling and other relevant technical information for the purposes of determining compliance with CAA section 110(a)(2)(D)(i)(I).

III. Final Action

In this action, the EPA is approving the Utah SIP with regard to certain interstate transport requirements of CAA section 110(a)(2)(D)(i) for the 2008 Pb and 2010 SO2 NAAQS from the State's certifications as shown in Table 2 of this preamble. The EPA is disapproving the Utah SIP with regard to certain interstate transport requirements of CAA section 110(a)(2)(D)(i) for the 2006 PM2.5, 2008 ozone, 2010 NO2 and 2012 PM2.5 NAAQS as shown in Table 3 of this preamble. As noted in our August 1, 2016 proposed action, the EPA is not required to take further action with regard to the prong 4 disapprovals, because a FIP is already in place for Utah that corrects all regional haze, and thus visibility transport, SIP deficiencies. 81 FR 43894. This action is being taken under section 110 of the CAA.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state actions, provided that they meet the criteria of the CAA. Accordingly, this action merely approves some state law provisions as meeting federal requirements and disapproves other state law because it does not meet federal requirements; this action does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994). In addition, the SIP does not apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 19, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See CAA section 307(b)(2).)

(b) Addition to the Utah State Implementation Plan regarding the 2008 Pb Standard for CAA section 110(a)(2)(D)(i) prongs 1, 2 and 4, submitted to EPA on January 19, 2012, and addition to the Utah SIP regarding the 2010 SO2 Standard for CAA section 110(a)(2)(D)(i) prong 4, submitted to EPA on June 2, 2013.

The Environmental Protection Agency (EPA) is taking direct final action to approve revisions to the California State Implementation Plan (SIP) concerning the base year emission inventories (EIs) for four areas designated as nonattainment areas (NAAs) for the 2008 ozone National Ambient Air Quality Standards (2008 ozone NAAQS). The subject areas include Calaveras County, Chico (Butte County), San Francisco Bay Area and San Luis Obispo (Eastern San Luis Obispo). We are approving these revisions under the Clean Air Act (CAA or “the Act”).

DATES:

This rule is effective on December 19, 2016 without further notice, unless the EPA receives adverse comments by November 18, 2016. If we receive such comments, we will publish a timely withdrawal in the Federal Register to notify the public that this direct final rule will not take effect.

ADDRESSES:

Submit your comments, identified by Docket ID No. EPA-R09-OAR-2016-0499 at http://www.regulations.gov, or via email to Nancy Levin, Air Planning Office at levin.nancy@epa.gov. For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be removed or edited from Regulations.gov. For either manner of submission, the EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud or other file sharing system). For additional submission methods, please contact the person identified in the FOR FURTHER INFORMATION CONTACT section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT:

Nancy Levin, EPA Region IX, (415) 972-3848, levin.nancy@epa.gov.

SUPPLEMENTARY INFORMATION:

Throughout this document, “we,” “us” and “our” refer to the EPA.

Table of ContentsI. BackgroundII. Summary and Analysis of the State's SubmittalA. Statutory and Regulatory Requirements1. Procedural Requirements for Adoption and Submittal of SIP Revisions2. Requirements for Base Year InventoriesB. Summary of the State's Submittal1. Stationary Source Emissions2. Area-wide Source Emissions3. Off-Road Mobile Source Emissions4. Onroad Mobile Source EmissionsC. The EPA's Evaluation of the State's Submittal1. Evaluation of Procedural Requirements2. Evaluation of Base Year Inventory RequirementsD. Public Comment and Final ActionIII. Statutory and Executive Order ReviewsI. Background

On March 12, 2008, the EPA strengthened the primary and secondary eight-hour ozone NAAQS to 0.075 parts per million (ppm) (73 FR 16436).1 In accordance with section 107(d) of the CAA, the EPA must designate an area “nonattainment” if it is violating the NAAQS or if it is contributing to a violation of the NAAQS in a nearby area.

1 Since the 2008 primary and secondary NAAQS for ozone are identical, for convenience, we refer to both as “the 2008 ozone NAAQS” or “the 2008 ozone standard.”

The EPA designated 18 areas in California as nonattainment for the 2008 ozone NAAQS on May 21, 2012, effective July 20, 2012 (77 FR 30088, codified at 40 CFR 81.305). The Calaveras County, Chico (Butte County), Imperial County, Kern County (Eastern Kern), Mariposa County, Nevada County (Western part), San Diego County, San Francisco Bay Area, San Luis Obispo (Eastern San Luis Obispo) and Tuscan Buttes NAAs were classified (by operation of law) as “Marginal” nonattainment. The EPA classified the Ventura County NAA as “Serious” nonattainment. The EPA classified the Los Angeles-San Bernardino Counties (West Mojave Desert), Riverside County (Coachella Valley) and Sacramento Metro NAAs as “Severe-15” nonattainment. The EPA classified the Los Angeles-South Coast Air Basin and San Joaquin Valley NAAs as “Extreme” nonattainment. The EPA designated the lands of the Pechanga Band of Luiseño Mission Indians of the Pechanga Reservation and the Morongo Band of Mission Indians in Southern California as separate NAAs and classified them as “Moderate” and Serious nonattainment, respectively.

2 The submittal did not include EIs for the Tuscan Buttes NAA, which is a small, high elevation area containing no anthropogenic sources, see submittal, p. 3, or for the Pechanga and Morongo NAAs.

On May 4, 2016 (81 FR 26697), the EPA issued one of three types of determinations for each NAA that was originally classified as Marginal for the 2008 ozone NAAQS. The EPA determined that four Marginal NAAs in California—Calaveras County, Chico (Butte County), San Francisco Bay Area and Tuscan Buttes—had attained the 2008 ozone NAAQS by the applicable attainment date of July 20, 2015, based on complete, quality-assured and certified ozone monitoring data for 2012-2014. The EPA determined that one NAA in California—San Luis Obispo (Eastern San Luis Obispo) (“Eastern SLO”)—qualified for a 1-year attainment date extension for the 2008 ozone NAAQS even though it did not attain the NAAQS by the applicable deadline. Finally, the EPA reclassified five NAAs in California as Moderate because they did not attain the 2008 ozone NAAQS by the attainment date and did not qualify for a 1-year extension. The EPA “bumped up” the following Marginal NAAs to Moderate: Imperial County, Kern County (Eastern Kern), Mariposa County, Nevada County (Western part) and San Diego County. In addition to the Marginal area requirements, which include submittal of a base year emission inventory (see CAA section 182(a)(1)), these NAAs became subject to additional requirements.3 However, these additional requirements are not the subject of this action.

3 These requirements include: An attainment demonstration; provisions for reasonably available control technology and reasonably available control measures; reasonable further progress (RFP) reductions in volatile organic compounds (VOC) and/or nitrogen oxide (NOX) emissions; contingency measures; a vehicle inspection and maintenance program; and NOX and VOC emission offsets at a ratio of 1.15 to 1 for major source permits (see 40 CFR part 51, subpart AA and CAA sections 182(b) and 172(c)). A SIP revision addressing these requirements is due to the EPA by January 1, 2017 (81 FR 26697, May 4, 2016).

In this action, we are acting on a portion of CARB's submittal, namely, the base year EIs for the Calaveras County, Chico (Butte County), Eastern SLO and San Francisco Bay Area NAAs. We are deferring action on the base year EIs for NAAs that are required to submit updated base year EIs to support their attainment demonstrations and to meet reasonable further progress requirements because we anticipate that these later submittals will supersede the EIs in the CARB 8-hour EI submittal for these areas.

II. Summary and Analysis of the State's SubmittalA. Statutory and Regulatory Requirements1. Procedural Requirements for Adoption and Submittal of SIP Revisions

CAA section 110(a)(1) and 110(l) and 40 CFR 51.102 require states to provide reasonable notice and an opportunity for a public hearing prior to adoption of SIP revisions. Section 110(k)(1)(B) requires the EPA to determine whether a SIP submittal is complete within 60 days of receipt. Any plan that we have not affirmatively determined to be complete or incomplete will become complete six months after the day of submittal by operation of law. A finding of completeness does not approve the submittal as part of the SIP nor does it indicate that the submittal is approvable. It does start a 12-month clock for the EPA to act on the SIP submittal (see CAA section 110(k)(2)).

2. Requirements for Base Year Inventories

CAA section 182(a)(1) and 40 CFR 51.1115(a) require states to submit a “base year inventory” for each 2008 ozone nonattainment area within two years of the effective date of designation. This inventory must be “a comprehensive, accurate, current inventory of actual emissions from sources of VOC and NOX emitted within the boundaries of the nonattainment area as required by CAA section 182(a)(1)” (40 CFR 51.1100(bb), see also CAA section 172(c)(3)). In addition, 40 CFR 51.1115(a) requires that the inventory year be selected consistent with the baseline year for the reasonable further progress (RFP) plan, which is usually the most recent calendar year for which a complete triennial inventory is required to be submitted to the EPA under the Air Emissions Reporting Requirements (40 CFR part 51, subpart A) (see 40 CFR 51.1110(b)).

B. Summary of the State's Submittal

The State submitted base year EIs for areas designated as nonattainment for the 2008 8-hour ozone NAAQS on July 17, 2014.4 CARB's submittal documents the public review process followed prior to its submittal to the EPA as a revision to the SIP. The submittal includes a copy of a CARB notice of public meeting on June 26, 2014 to consider the approval of the submittal, a transcript from the June 26, 2014 meeting,5 and a signed resolution stating that the CARB made the EIs available for public review at least 30 days prior to the board hearing and that the EIs were adopted after notice and public hearing.6 As noted above, on September 2, 2016, CARB provided additional technical information referred to herein as EI Supplemental Documentation to support the NAA EIs submitted on July 17, 2014.

CARB selected 2012 as the base year because it was the most recent year for which comprehensive emissions estimates were available,7 and because CARB wanted a consistent inventory across the state.8 The submitted base year EIs are expressed as 2012 average summer day emissions in tons per day (tpd) and categorized as stationary point sources, area-wide sources, on-road mobile sources and other mobile sources. CARB's EI Supplemental Documentation describes methods used to estimate emissions for each category and subcategory.9 The submittal describes the updates to the 2012 EIs since the last comprehensive EI update, and it also describes how emissions were calculated for “split regions” not defined by CARB's county, air basin, and district boundaries.10

7 Submittal, p. 5.

8 In particular, CARB wanted to assure consistency with the South Coast Air Quality Management District, which planned to use 2012 data for its base year inventory. See Supplemental Documentation.

CARB estimates stationary point source emissions based on annual reports submitted by the local air districts. The local air districts are responsible for working with facility operators to compile estimates, using source testing, direct measurement or engineering calculations. CARB estimates emissions from smaller point sources, such as gasoline dispensing facilities and residential water heaters, as a group and reports them in a single source category. CARB groups stationary point source emissions into the following categories: Fuel combustion, waste disposal, cleaning and surface coatings, petroleum production and marketing, and industrial processes.12

CARB describes the methodologies it uses for smaller point sources in the EI Supplemental Documentation. For example, while CARB reports most of the food and agricultural processing emission sources as individual point sources, CARB estimates the exhaust emissions from agricultural irrigation pumps from a model developed by CARB staff. The EI Supplemental Documentation provides a link to the methodology used.13 The model uses United States Department of Agriculture (USDA) engine population estimates, emission factors, average annual use in hours, average brake horsepower of engine and average engine load factors.14

CARB's area-wide source inventories include categories where emissions take place over a wide geographic area, such as consumer products, residential fuel combustion and farming operations. CARB groups area-wide source emissions as either solvent evaporation or miscellaneous processes.15

CARB describes the methodologies for each area-wide source emission category in the EI Supplemental Documentation, pages 21-29. CARB uses various methodologies for estimating emissions from area-wide source categories. For example, the California Department of Pesticide Regulation (DPR) calculates pesticide emission estimates for CARB. The DPR applies Emission Potential (EP) values from the DPR database to the amount of grower-reported pesticide application in DPR's Pesticide Use Report database.16 For the consumer products emissions estimates, CARB conducted surveys to collect updated product and ingredient information for approximately 360 consumer product categories, and determined the total sales and total VOC emissions for each category based on the survey data. CARB adjusted emissions to the 2012 base year by using population data from the California Department of Finance (2013).17 CARB bases emissions from farming operations on data from the USDA's 2012 Census of Agriculture and emission factors for each livestock category.18 CARB uses survey data and emission factors to estimate emissions from residential wood combustion, a subcategory of residential fuel combustion. In 2011, CARB updated its methodology for residential wood combustion to include more recent survey data on residential wood burning devices and consumption rates, updates to the EPA National Emission Inventory emission factors and improved calculation approaches.19

16 The EP value is the fraction of the product that is assumed to potentially contribute to atmospheric VOC. California's pesticide use reporting program requires that all agricultural pesticide use must be reported monthly by growers to county agricultural commissions, who in turn, report the data to DPR. See http://www.cdpr.ca.gov/docs/pur/purmain.htm.

CARB has developed category-specific models for numerous off-road (also known as “non-road”) sources, including locomotives, ships, industrial and construction equipment, and recreational vehicles. CARB used the OFFROAD2007 model for categories without source-specific models. CARB provided supplementary documentation describing the methodologies used for the following off-road sources: Aircraft, ocean going vessels, commercial harbor craft, recreational boats, off-road recreational vehicles, fuel storage and handling equipment, farm equipment and off-road equipment (i.e., transport refrigeration units, drill rigs, cargo handling equipment, and trains).20 The submittal provided emission estimates for off-road sources that reflected updates to data models for ocean going vessels, recreational boats, recreational vehicles, off-road equipment and farm equipment.21 In addition to describing each category, CARB provides Web site links to additional information on each methodology. These descriptions include the type of source represented, the types and source of data used, and the models used. For example, CARB describes ocean-going vessels (OGVs) as commercial vessels greater than or equal to 400 feet in length or 10,000 gross tons or propelled by a marine compression ignition engine with a displacement of greater than or equal to 30 liters per cylinder. CARB's emission inventory includes all OGV emissions occurring within 100 nautical miles of the California coastline.

20 EI Supplemental Documentation, pp. 4-10.

21 See submittal p. 6.

4. On-Road Mobile Source Emissions

CARB estimated on-road mobile emissions from cars, light and heavy-duty trucks, motorcycles, buses and motor homes using its Emission Factors (EMFAC) model version 2011, which was the latest EPA-approved version available at the time the EIs were prepared.22 CARB estimated vehicle populations using registration data from the Department of Motor Vehicles (DMV), updated in 2012.23 The model estimates vehicle miles traveled (VMT) from data and mileage accrual rates from the Bureau of Automotive Smog Check Program. CARB states that the EIs in this submittal reflect updates to the EMFAC2011 activity parameters, including vehicle population and activity using 2012 DMV data, vehicle sales and survival rate estimates, fuel sales from the Board of Equalization, and updates to mileage accrual rates using Smog Check data. CARB adjusted the default VMT regional allocations using the 2012 National Transportation Atlas Database. The model also reflects the emissions benefits of CARB's 2010 Truck and Bus Regulation, the “Pavley” Clean Car Standards and the Low Carbon Fuel Standard. CARB provides additional information on EMFAC at http://www.arb.ca.gov/mseimsei.htm.

22 On March 16, 2013, the EPA approved and announced the availability of EMFAC2011 as the latest update to the EMFAC model for use in SIP development and transportation conformity by California state and local governments to meet CAA requirements (78 FR 14533). On December 14, 2015, the EPA announced the next revision to EMFAC—EMFAC 2014 (80 FR 77337). CARB submitted the 2008 8-hour ozone EI submittal after the EPA's approval of EMFAC2011 and prior to the EPA's approval of EMFAC2014.

23 EI Supplemental Documentation, p. 3.

C. The EPA's Evaluation of the State's Submittal1. Evaluation of Procedural Requirements

Based on the documentation included in CARB's submittal, we find that the submittal satisfies the procedural requirements of sections 110(a)(1) and 110(l) of the Act requiring states to provide reasonable notice and an opportunity for public hearing prior to adoption of SIP revisions. CARB's submittal became complete by operation of law on January 17, 2015 pursuant to section 110(k)(1)(B).

2. Evaluation of Base Year Inventory Requirements

The EPA has reviewed the 2012 average summer day base year EIs for the Calaveras County, Chico (Butte County), Eastern SLO and San Francisco Bay Area NAAs. Our review included the emission estimates for stationary sources, area-wide sources and mobile sources. We find that CARB's selection of 2012 as the base year was appropriate for these areas because 2012 was the most recent calendar year for which a consistent and comprehensive statewide inventory was available.24 The submittal and EI Supplemental Documentation provide sufficient information and explanation to allow the EPA to make a determination on the acceptability of the EIs. Accordingly, we conclude that the EIs constitute a comprehensive, accurate, current inventory of actual emissions from sources of VOC and NOX emitted within the boundaries of the relevant NAAs, as required under the CAA and SRR (40 CFR 51.1100(bb), see also CAA section 172(c)(3)).

24 We also note that, because the State is not required to submit an RFP plan for Marginal areas, the requirement for the inventory year selected to be consistent with the baseline year for the RFP plan is not relevant to these areas.

D. Public Comment and Final Action

As authorized in section 110(k)(3) of the Act, the EPA is fully approving the submitted EIs for the Calaveras County, Chico (Butte County), San Luis Obispo County (Eastern SLO) and San Francisco Bay Area NAAs because we believe they fulfill all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this Federal Register, we are simultaneously proposing approval of the same submitted EIs. If we receive adverse comments by November 18, 2016, we will publish a timely withdrawal in the Federal Register to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on December 19, 2016.

III. Statutory and Executive Order Reviews

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves a state plan as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 19, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the Proposed Rules section of today's Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that the EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).

This regulation establishes tolerances for residues of penflufen in or on vegetable, bulb, group 3-07; beet, sugar, roots; and beet, sugar, tops. Interregional Research Project Number 4 (IR-4) requested the tolerance associated with pesticide petition number (PP#) 5E8382, and Bayer CropScience requested the tolerances associated with PP# 5F8379, under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES:

This regulation is effective October 19, 2016. Objections and requests for hearings must be received on or before December 19, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES:

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0559, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0559 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 19, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0559, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.II. Summary of Petitioned-for Tolerance

In the Federal Register of October 21, 2015 (80 FR 63731) (FRL-9935-29), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP# 5E8382) by Interregional Research Project Number 4 (IR-4), 500 College Road East, Princeton, NJ 08540. The petition requested that 40 CFR 180.664 be amended by establishing tolerances for residues of the fungicide penflufen, (1H-Pyrazole-4-carboxamide, N-[2-(1,3-dimethylbutyl)phenyl]-5-fluoro-1,3-dimethyl-), in or on onion, bulb, 3-07A at 0.01 parts per million (ppm); and onion, green, 3-07B at 0.015 ppm. That document referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available in the docket EPA-HQ-OPP-2015-0559-0002 at http://www.regulations.gov.

In the Federal Register of July 20, 2016 (81 FR 47150) (FRL-9948-45), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP# 5F8379) by Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.664 be amended by establishing tolerances for residues of the fungicide penflufen, (1H-Pyrazole-4-carboxamide, N-[2-(1,3-dimethylbutyl)phenyl]-5-fluoro-1,3-dimethyl-), in or on beet, sugar, roots at 0.01 ppm and beet, sugar, tops at 0.01 ppm. That document referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available in the docket EPA-HQ-OPP-2015-0559-0006 at http://www.regulations.gov.

Five comments were received in response to the notices of filing. EPA's responses to these comments are discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA has revised the petitioned-for tolerances for subgroups 3-07A and 3-07B since the Agency has determined that a crop group tolerance for vegetable, bulb, group 3-07 is more appropriate. The reason for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for penflufen including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with penflufen follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

The liver and thyroid are target organs for penflufen. No evidence of quantitative or qualitative susceptibility was seen in developmental toxicity studies (rats and rabbits). Developmental toxicity was not observed in the rat or rabbit studies, although the studies did not test up to the limit dose. However, new studies are not expected to identify developmental endpoints with points of departure (PODs) lower than those determined in the current studies. In the reproductive study, decreased pup weight, delayed vaginal patency, and decreased brain, spleen, and thymus weights were seen in the presence of limited maternal effects (body weight changes), suggesting qualitative sensitivity. However, concern for the sensitivity is low since the effects are well characterized, and there is a clear NOAEL for the effects seen. Decreased motor and locomotor activity were observed in both sexes of rats following acute oral exposure and in female rats following subchronic oral exposure; neuropathological lesions were not observed in either study.

Penflufen is classified as having “suggestive evidence of carcinogenicity.” A statistically significant increase in histiocytic sarcomas with a positive trend in male rats only (but in the absence of a dose response and lack of pre-neoplastic lesions) was seen. A marginal increase in brain astrocytomas was also observed in males at the high dose; however, this effect was not dose-related, did not reach statistical significance, and there was no overall trend. In addition, there were no pre-neoplastic lesions, such as glial proliferations, which are a good indicator of chemical tumor induction (i.e., there will be changes in the cells prior to transformation to a neoplasm). The ovarian adenomas observed at the high dose also showed no dose response, no pair-wise significance, no decrease in latency, and there were no pre-neoplastic lesions such as hyperplasia of the epithelial cells of the endometrium. Additionally, there was no evidence of carcinogenicity in male or female mice (at doses that were judged to be adequate to assess the carcinogenic potential), no concern for mutagenicity (in vivo or in vitro) for the parent molecule or the two metabolites, and there were no other lines of evidence of carcinogenicity (such as structure-activity relationship). Although these three tumors were considered treatment-related, they provided weak evidence of carcinogenicity due to the marginal nature of the tumor responses and the other factors mentioned above. Given the weak evidence indicating any potential for carcinogenicity, EPA has determined that quantification of risk using a non-linear approach (i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity, which could result from exposure to penflufen. The NOAEL (38 mg/kg/day) used for establishing the chronic RfD is approximately 10-fold lower than the dose (approximately 300 mg/kg/day) that induced a marginal tumor response. The EPA has determined that the chronic population adjusted dose is protective of all long-term effects, including potential carcinogenicity, based on limited evidence for carcinogenicity (histiocytic sarcomas) in male rats. There is no mutagenicity concern for penflufen. The risk assessments conducted for penflufen are based on the most sensitive endpoints in the toxicity database and are protective of all effects observed in the toxicology database.

Specific information on the studies received and the nature of the adverse effects caused by penflufen as well as the NOAEL and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document “Penflufen. Human Health Risk Assessment to Support New Uses on Bulb Vegetables (Crop Group 3-07) and Sugar Beets.” in pages 8-12 in docket ID number EPA-HQ-OPP-2015-0559.

B. Toxicological Points of Departure/Levels of Concern

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

A summary of the toxicological endpoints for penflufen used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of May 14, 2012 (77 FR 28278) (FRL-9341-8).

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to penflufen, EPA considered exposure under the petitioned-for tolerances as well as all existing penflufen tolerances in 40 CFR 180.664. EPA assessed dietary exposures from penflufen in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

Such effects were identified for penflufen. In estimating acute dietary exposure, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This software uses 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA used tolerance-level residues, default processing factors, and 100 percent crop treated (PCT) for all commodities.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the DEEM-FCID, Version 3.16 software with 2003-2008 food consumption data from the USDA's NHANES/WWEIA. As to residue levels in food, EPA used tolerance-level residues, default processing factors, and 100 PCT for all commodities.

iii. Cancer. EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a food-use pesticide based on the weight of the evidence from cancer studies and other relevant data. Cancer risk is quantified using a linear or nonlinear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or nonlinear approach is used and a cancer RfD is calculated based on an earlier noncancer key event. If carcinogenic mode of action data are not available, or if the mode of action data determines a mutagenic mode of action, a default linear cancer slope factor approach is utilized. Based on the data summarized in Unit III.A., EPA has determined that quantification of risk using a non-linear approach (i.e., cRfD) will adequately account for all chronic toxicity, including carcinogenicity, which could result from exposure to penflufen. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue or PCT information in the dietary assessment for penflufen. Tolerance level residues and 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water.

In drinking water, the residue of concern is penflufen parent and its degradates, penflufen-hydroxybutyl (Pen-3HB) and penflufen-pyrazolyl-AAP (AAP). The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for penflufen in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of penflufen. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the Surface Water Concentration Calculator (SWCC) and Pesticide Root Zone Model Ground Water (PRZM GW) models, the estimated drinking water concentrations (EDWCs) of penflufen for acute exposures are estimated to be 5.09 parts per billion (ppb) for surface water and 123 ppb for ground water. The EDWCs of penflufen for chronic exposures for non-cancer assessments are estimated to be 3.95 ppb for surface water and 84.8 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 123 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 84.8 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Penflufen is not registered for any specific use patterns that would result in residential exposure.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found penflufen to share a common mechanism of toxicity with any other substances, and penflufen does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that penflufen does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. No evidence of quantitative or qualitative susceptibility was seen in developmental toxicity studies in rats and rabbits. In the rat and rabbit developmental toxicity studies, maternal findings were limited to decreased body weight gain at the highest doses tested (HDT). No adverse effects were observed in rat or rabbit fetuses. In the rat multi-generation reproduction study, a slight decrease in litter size, delayed sexual maturation, decreased body weight and weight gain, and decreased brain, spleen, and thymus weights were noted in the offspring animals in the presence of less pronounced maternal toxicity (decreased body weight and weight gain, alteration in food consumption, decreased thymus weight, and decreased spleen weights) suggesting qualitative susceptibility.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for penflufen is complete.

ii. There is no concern for neurotoxicity and no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. Although clinical signs were observed in acute and subchronic neurotoxicity studies with penflufen, there is a clear NOAEL for the effects seen and the endpoints and PODs selected for risk assessment are protective. The NOAELs used for risk assessment are 2x lower than where clinical signs were observed.

iii. Although there is some evidence of qualitative sensitivity of the young in the reproduction study, the effects are well characterized, and there is a clear NOAEL for effects seen. Also, the current risk assessments are based on the most sensitive endpoints derived from studies with NOAELs 5x lower than the doses at which offspring effects were observed in the reproductive toxicity study. Thus, the PODs selected for risk assessment are protective of potential offspring effects.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to penflufen in drinking water. These assessments will not underestimate the exposure and risks posed by penflufen.

E. Aggregate Risks and Determination of Safety

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to penflufen will occupy 4.2% of the aPAD for all infants (<1 year old), the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to penflufen from food and water will utilize 1.2% of the cPAD for all infants (<2 year old) the population group receiving the greatest exposure. There are no residential uses for penflufen.

3. Short- and intermediate-term risk. Short- and intermediate-term adverse effects were not identified; however, penflufen is not registered for any use patterns that would result in short- or intermediate-term residential exposures. Short- and intermediate-term risks are assessed based on short- and intermediate-term residential exposures plus chronic dietary exposure, respectively. Because there are no short- and intermediate-term residential exposures, and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short- or intermediate-term risks are necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risks for penflufen.

4. Aggregate cancer risk for U.S. population. EPA assessed cancer risk using a non-linear approach (i.e., RfD) since it adequately accounts for all chronic toxicity, including carcinogenicity, that could result from exposure to penflufen. As the chronic dietary endpoint and dose are protective of potential cancer effects, penflufen is not expected to pose an aggregate cancer risk.

5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to penflufen residues.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for penflufen.

C. Response to Comments

One comment was received in response to the Notice of Filing for PP# 5E8382. The commenter was opposing the use and sale of penflufen in the United States. The Agency understands the commenter's concerns and recognizes that some individuals believe that pesticides should be banned on agricultural crops. However, the existing legal framework provided by Section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. EPA has found that there is a reasonable certainty of no harm to humans after considering the toxicological studies and the exposure levels of humans to penflufen.

Three comments were received in response to the Notice of Filing for PP# 5F8379. One comment was in support of the Proposed Rule, while two comments were opposing any tolerance level above 0.00 ppm for any pesticides used in the U.S. The Agency understands the commenter's concerns and recognizes that some individuals believe that pesticides should be banned on agricultural crops. However, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. In addition, both commenters indicated that IR-4 and Rutgers University are profiteering. The IR-4 program was created by Congress in 1963 in order to assist minor crop growers in the process of obtaining pesticide registrations. IR-4 National Coordinating Headquarters is located at Rutgers University in New Jersey and receives the majority (90%) of its funding from the USDA. It is the only publicly funded program that conducts research and submits petitions for tolerances. IR-4 operates in collaboration with USDA, the Land Grant University System, the agrochemical industry, commodity associations, and EPA. IR-4 identifies needs, prioritizes accordingly, and conducts research. The majority (over 80%) of IR-4's research is conducted on reduced-risk chemicals. Under the Pesticide Registration Improvement Act (PRIA), IR-4 works in cooperation with the registrant to request an exemption for the registration services. The exemption may be granted if the application is solely associated by simultaneous submission with a tolerance petition in connection with IR-4 and if it is in the public interest. This fee exemption serves as an incentive to pursue registration of minor uses supported by the IR-4 program. In addition to the work done in pesticide registration, IR-4 develops risk mitigation measures for existing registered products. Therefore, IR-4 and Rutgers University are not profiteering from registering pesticides.

A comment was submitted by the Environmental Health Program of the Center for Biological Diversity and was primarily concerned about environmental risks and Agency compliance with any relevant obligations under the Endangered Species Act. This comment is not relevant to the Agency's evaluation of safety of the penflufen tolerances; section 408 of the FFDCA focuses on potential harms to human health and does not permit consideration of effects on the environment.

D. Revisions to Petitioned-for Tolerances

Based on review of the data supporting the petitions, EPA has revised the petitioned-for tolerance on onion, green, subgroup 3-07B. Both representative commodities for crop group 3-07 were submitted for the new uses, which included different tolerances proposed for crop subgroup 3-07A and 3-07B. Although the petitioner requested separate tolerances (based on the Organization for Economic Cooperation and Development (OECD) calculation procedure), EPA has decided to establish a tolerance for crop group 3-07 at the level of qualification (LOQ) of the enforcement method (0.01 ppm), because maximum residues from crop subgroup 3-07A and subgroup 3-07B representative commodities were within a five-fold difference of each other, and because with residues in the field trials all less than the LOQ, the OECD calculation procedure stipulates that the LOQ is the appropriate tolerance level. Therefore, a single tolerance on the crop group vegetable, bulb, group 3-07 is appropriate.

V. Conclusion

Therefore, tolerances are established for residues of penflufen, in or on vegetable, bulb, group 3-07 at 0.01 ppm; beet, sugar, roots at 0.01 ppm; and beet, sugar, tops at 0.01 ppm.

VI. Statutory and Executive Order Reviews

This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:

Temporary rule; inseason retention limit adjustment.

SUMMARY:

NMFS is adjusting the commercial aggregated large coastal shark (LCS) and hammerhead shark management group retention limit for directed shark limited access permit holders in the Atlantic region from 45 LCS other than sandbar sharks per vessel per trip to 25 LCS other than sandbar sharks per vessel per trip. This action is based on consideration of the regulatory determination criteria regarding inseason adjustments. The retention limit will remain at 25 LCS other than sandbar sharks per vessel per trip in the Atlantic region through the rest of the 2016 fishing season or until NMFS announces via a notice in the Federal Register a fishery closure is warranted. This retention limit adjustment will affect directed shark limited access permit holders fishing for LCS in the Atlantic region.

DATES:

This retention limit adjustment is effective at 11:30 p.m. local time October 19, 2016, through the end of the 2016 fishing season on December 31, 2016, or until NMFS announces via a notice in the Federal Register a fishery closure, if warranted.

Under § 635.24(a)(8), NMFS may adjust the commercial retention limit in the shark fisheries during the fishing season. Before making any adjustment, NMFS must consider specified regulatory criteria and other relevant factors. See § 635.24(a)(8)(i)-(vi). After considering these criteria as discussed below, NMFS concluded that reducing the retention limit of the Atlantic aggregated LCS and hammerhead management groups for directed shark limited access permit holders will slow the fishery catch rates to allow the fishery throughout the Atlantic region to remain open for the rest of the year. Since landings are projected to reach 80 percent before the end of the 2016 fishing season, NMFS is reducing the commercial Atlantic aggregated LCS and hammerhead shark retention limit from 45 to 25 LCS other than sandbar per vessel per trip.

• The amount of remaining shark quota in the Atlantic region based on dealer reports;

Based on dealer reports, 108.6 mt dw or 64 percent of the 168.9 mt dw shark quota for the aggregated LCS management group has already been harvested in the Atlantic region. This means that approximately 36 percent of the quota remains. Unless action is taken to slow harvest, fishermen in the Atlantic region may not have an opportunity to fish in the region for the remainder of the year.

• The catch rates of the aggregated LCS management group in the Atlantic region based on dealer reports;

Based on dealer reports, the current catch rates are too high to maintain an open season for the rest of the year. While fishermen are landing sharks within the per-trip retention limit of 45 LCS other than sandbar per trip per day, they are making multiple trips a day that result in high numbers of aggregated LCS being caught rapidly throughout the fishery. This high daily average catch rate means that aggregated LCS are being harvested too quickly to provide equitable fishing opportunities throughout the season. If the per trip limit is left unchanged, aggregated LCS would likely be harvested at such a high rate that the fishery would close in mid-October.

• Estimated date of the aggregated LCS management group closure based on when the landings are projected to reach 80 percent of the quota;

Once the landings reach 80 percent of the quota, NMFS would close the aggregated LCS management group as well as any other management group with “linked quotas” such as the Atlantic hammerhead shark management group. Current catch rates would likely result in landings reaching this limit by mid-October. A closure would preclude fishing opportunities in the Atlantic region for the remainder of the year. Reducing the trip limit is expected to reduce the catch rates and allow for the fishery to remain open for the remainder of the year.

• Effects of the adjustment on accomplishing the objectives of the 2006 Consolidated HMS FMP and its amendments;

Reducing the retention limit for the aggregated LCS and hammerhead management group from 45 to 25 LCS per trip would allow for fishing opportunities later in the year consistent with the FMP's objectives to provide equitable fishing opportunities throughout the fishing season and to limit bycatch and discards.

• Variations in seasonal distribution or migratory patterns of aggregated LCS based on scientific and fishery-based knowledge; and

The directed shark fisheries in the Atlantic region exhibit a mixed species composition, with a high abundance of aggregated LCS caught in conjunction with hammerhead sharks. As a result, by slowing the harvest and reducing landings on a per-trip basis, both fisheries could remain open for the remainder of the year.

• Effects of catch rates in one part of the Atlantic region precluding vessels in another part from having a reasonable opportunity to harvest a portion of the aggregated LCS management group quota.

Based on dealer reports, and given NMFS' notice to the regulated community (80 FR 74999, December 1, 2015; 81 FR 18541, March 31, 2016; and 81 FR 44798, July 11, 2016) that a goal of this year's fishery was to provide fishing opportunities throughout the fishing season, NMFS has concluded that the aggregated LCS quota is being harvested too quickly to meet conservation and management goals for the fishery. If the harvest of these species is not slowed down, the fishery would likely close in mid-October. Closing the fishery would prevent fishermen from other parts of the Atlantic region from having the same opportunities to harvest the aggregated LCS quota later in the year.

On December 1, 2015 (80 FR 74999), NMFS announced in a final rule that the aggregated LCS and hammerhead shark fisheries management groups for the Atlantic region would open on January 1 with a quota of 168.9 metric tons (mt) dressed weight (dw) (372,552 lb dw) and 27.1 mt dw (59,736 lb dw), respectively. NMFS had published a proposed rule on August 18, 2015 (80 FR 49974) and accepted public comment. In the final rule, NMFS also announced that if it appeared that the quota is being harvested too quickly, thus precluding fishing opportunities throughout the entire region (e.g., if approximately 20 percent of the quota is caught at the beginning of the year), NMFS would consider reducing the commercial retention limit to 3 or fewer LCS other than sandbar sharks and then later consider increasing the retention limit to 45 LCS other than sandbar sharks per vessel per trip around July 15, 2016, after considering the appropriate regulatory adjustment criteria. In March 2016, dealer reports indicated that landings had exceeded 20 percent of the quota, and NMFS therefore reduced the commercial Atlantic aggregated LCS and hammerhead shark retention limit from 36 to 3 LCS other than sandbar per vessel per trip on April 2, 2016 (81 FR 18541; March 31, 2016) after considering the inseason retention limit adjustment criteria listed at § 635.24(a)(8). As NMFS announced in the 2016 shark season final rule (81 FR 44798; July 11, 2016), we increased the commercial Atlantic aggregated LCS and hammerhead shark retention limit from 3 to 45 LCS other than sandbar per vessel per trip after considering the regulatory criteria. Based on dealer reports through September 30, 2016, approximately 34 percent and 54 percent of the aggregated LCS and hammerhead shark quotas remain, respectively. At this point in the season, fishermen in the Atlantic region may not have an opportunity to fish in the region for the remainder of the year if the retention limits are not reduced.

Accordingly, as of 11:30 p.m. local time October 19, 2016, NMFS is reducing the retention limit for the commercial aggregated LCS and hammerhead shark management groups in the Atlantic region for directed shark limited access permit holders from 45 LCS other than sandbar sharks per vessel per trip to 25 LCS other than sandbar sharks per vessel per trip. If the vessel is properly permitted to operate as a charter vessel or headboat for HMS and is engaged in a for-hire trip, in which case the recreational retention limits for sharks and “no sale” provisions apply (§ 635.22(a) and (c)), or if the vessel possesses a valid shark research permit under § 635.32 and a NMFS-approved observer is onboard, then they are exempted from the retention limit adjustment.

All other retention limits and shark fisheries in the Atlantic region remain unchanged. This retention limit will remain at 25 LCS other than sandbar sharks per vessel per trip for the rest of the 2016 fishing season, or until NMFS announces via a notice in the Federal Register a fishery closure, is warranted.

The boundary between the Gulf of Mexico region and the Atlantic region is defined at § 635.27(b)(1) as a line beginning on the East Coast of Florida at the mainland at 25°20.4′ N. lat., proceeding due east. Any water and land to the north and east of that boundary is considered, for the purposes of quota monitoring and setting of quotas, to be within the Atlantic region.

Classification

Pursuant to 5 U.S.C. 553(b)(B), the Assistant Administrator for Fisheries, NOAA (AA), finds there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest. Providing prior notice and an opportunity for comment is impracticable because the catch and landings that need to be reduced are ongoing and must be reduced immediately to meet conservation and management objectives for the fishery. Continued fishing at those levels during the time that notice and comment would take place would likely result in early closure of the fishery, contrary to the objectives of the existing conservation and management measures in place for these species. These objectives include providing equitable fishing opportunities and ensuring that bycatch and discards are minimized. Allowing fishing to continue at the existing rates even for a limited time is contrary to these objectives and would thus be impracticable. It would also be contrary to the public interest because continued catch at the current rates, even for a limited period, could result in eventual early quota closures and potential overharvests. The AA also finds good cause to waive the 30-day delay in effective date pursuant to 5 U.S.C. 553(d)(3) for the same reasons. This action is required under § 635.28(b)(2) and is exempt from review under Executive Order 12866. NMFS has concluded that reducing the retention limit of the Atlantic aggregated LCS and hammerhead management groups for directed shark limited access permit holders will slow the fishery catch rates to allow the fishery throughout the Atlantic region to remain open for the rest of the year.

National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:

Temporary rule; closure.

SUMMARY:

NMFS is closing the directed fishery for Atlantic herring in Herring Management Area 1A, based on a projection that a prescribed trigger for that area has been reached. Federally permitted vessels may not fish for, possess, transfer, receive, land, or sell more than an incidental amount of Atlantic herring in or from Area 1A through December 31, 2016, and federally permitted dealers may not purchase more than this incidental amount of herring from federally permitted vessels for the duration of this action. This action is necessary to comply with the regulations implementing the Atlantic Herring Fishery Management Plan and is intended to prevent over harvest in Area 1A.

DATES:

Effective 00:01 hr local time, October 18, 2016, through December 31, 2016.

FOR FURTHER INFORMATION CONTACT:

Shannah Jaburek, Fishery Management Specialist, (978) 282-8456.

SUPPLEMENTARY INFORMATION:

Regulations governing the Atlantic herring fishery can be found at 50 CFR part 648, including requirements for setting annual catch allocations. NMFS set the 2016 Area 1A sub-annual catch limit (ACL) at 30,102 mt, based on an initial 2016 sub-ACL allocation of 31,200 mt, minus a deduction of 936 mt for research set-aside catch, plus an increase of 133 mt to account for unharvested 2014 catch. Additionally, NMFS further reduced the Area 1A sub-ACL of 30,102 mt by 295 mt to allow for the fixed gear set-aside, that, if unharvested, will be added back into the Area 1A sub-ACL after November 1. NMFS established these values in the 2013 through 2015 specifications (78 FR 61828, October 1, 2013) and a final rule implementing sub-ACL adjustments for 2016 (81 FR 12420, March 9, 2015). For Area 1A, NMFS restricts herring catch to the seasonal period from June 1 through December 31. NMFS prohibits vessels from catching herring during the seasonal period from January 1 through May 31.

The Administrator, Greater Atlantic Region, NMFS (Regional Administrator), monitors the herring fishery catch in each of the management areas based on vessel and dealer reports, state data, and other available information. The regulations at § 648.201 require that when Regional Administrator projects that herring catch will reach 92 percent of the sub-ACL allocated in the Area 1A seasonal management area designated in the Atlantic Herring Fishery Management Plan (FMP), NMFS must prohibit, through notification in the Federal Register, herring vessel permit holders from fishing for, possessing, transferring, receiving, landing, or selling more than 2,000 lb (907.2 kg) of herring per trip or calendar day in or from the specified management area for the remainder of the fishing year.

The Regional Administrator has determined, based on vessel and dealer reports, state data, and other available information, that the herring fleet will have caught 92 percent of the herring sub-ACL allocated to Area 1A by October 18, 2016. Therefore, effective 00:01 hr local time, October 18, 2016, federally permitted vessels may not fish for, catch, possess, transfer, land, or sell more than 2,000 lb (907.2 kg) of herring per trip or calendar day, in or from Area 1A through December 31, 2016. With one exception, vessels that have entered port before 00:01 hr local time, October 18, 2016, may land and sell more than 2,000 lb (907.2 kg) of herring from Area 1A from that trip. The exception provides that a vessel may transit through Area 1A with more than 2,000 lb (907.2 kg) of herring on board, provided all herring was caught outside of Area 1A and all fishing gear is stowed and not available for immediate use as defined by § 648.2. In addition, all herring vessels must land in accordance with state landing restrictions.

Effective 00:01 hr local time, October 18, 2016, federally permitted dealers may not receive herring from federally permitted herring vessels that harvest more than 2,000 lb (907.2 kg) of herring from Area 1A through 2400 hr local time, December 31, 2016, unless it is from a trip landed by a vessel that entered port before 00:01 hr local time, October 18, 2016, and that catch is landed in accordance with state regulations.

Classification

This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.

NMFS finds good cause pursuant to 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment because it would be contrary to the public interest and impracticable. This action restricts the catch of herring in Area 1A for the remainder of the fishing year. Data indicating the herring fleet will have landed at least 92 percent of the 2016 sub-ACL allocated to Area 1A have only recently become available. Once these data become available, NMFS is required by Federal regulation to implement a 2,000-lb (907.2-kg) herring possession limit for Area 1A through December 31, 2016. The regulations at § 648.201(a)(1)(i) require such action to ensure that herring vessels do not exceed the 2016 sub-ACL allocated to Area 1A. If implementation of this closure is delayed to solicit prior public comment, the sub-ACL for Area 1A for this fishing year will likely be exceeded, thereby undermining the conservation objectives of the FMP. If sub-ACLs are exceeded, the excess must also be deducted from a future sub-ACL and would reduce future fishing opportunities. NMFS further finds, pursuant to 5 U.S.C. 553(d)(3), good cause to waive the 30-day delayed effectiveness period for the reasons stated above.

National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:

Temporary rule; closure.

SUMMARY:

NMFS is prohibiting directed fishing for Pacific cod by catcher/processors using pot gear in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the 2016 Pacific cod total allowable catch allocated to catcher/processors using pot gear in the BSAI.

NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2016 Pacific cod total allowable catch (TAC) allocated to catcher/processors using pot gear in the BSAI is 4,357 metric tons (mt) as established by the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016) and reallocation (81 FR 69445, October 6, 2016).

In accordance with § 679.20(d)(1)(iii), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2016 Pacific cod TAC allocated as a directed fishing allowance to catcher/processors using pot gear in the BSAI will soon be reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by pot catcher/processors in the BSAI.

After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

Classification

This action responds to the best available information recently obtained from the fishery. The Acting Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of directed fishing for Pacific cod by pot catcher/processors in the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of October 13, 2016.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.

The Environmental Protection Agency (EPA) is proposing to approve revisions to the California State Implementation Plan (SIP) concerning the base year emission inventories (EIs) for four areas designated as nonattainment areas for the 2008 ozone National Ambient Air Quality Standards (2008 ozone NAAQS). The subject areas include Calaveras County, Chico (Butte County), San Francisco Bay Area and San Luis Obispo (Eastern San Luis Obispo). We are proposing to approve these revisions under the Clean Air Act (CAA or the Act).

DATES:

Any comments on this proposal must arrive by November 18, 2016.

ADDRESSES:

Submit your comments, identified by Docket ID No. EPA-R09-OAR-2016-0499 at http://www.regulations.gov, or via email to Nancy Levin, Air Planning Office at levin.nancy@epa.gov. For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be removed or edited from Regulations.gov. For either manner of submission, the EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the Web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the FOR FURTHER INFORMATION CONTACT section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT:

Nancy Levin, EPA Region IX, (415) 972-3848, levin.nancy@epa.gov.

SUPPLEMENTARY INFORMATION:

Throughout this document, “we,” “us” and “our” refer to the EPA. This proposal addresses base year EIs for the Calaveras County, Chico (Butte County), San Francisco Bay Area and San Luis Obispo (Eastern San Luis Obispo) 2008 ozone NAAQS nonattainment areas. We are approving these base year EIs in a direct final action without prior proposal because we believe these SIP revisions are not controversial. If we receive adverse comments, however, we will publish a timely withdrawal of the direct final rule and address the comments in subsequent action based on this proposed rule. Please note that if we receive adverse comment on a particular base year EI, we may adopt as final those that are not the subject of an adverse comment.

We do not plan to open a second comment period, so anyone interested in commenting should do so at this time. If we do not receive adverse comments, no further activity is planned. For further information, please see the direct final action.

The Coast Guard proposes new base pilotage rates and surcharges using the methodology instituted in 2016. The changes would take effect 30 days after publication of a final rule. Rates for pilotage services on the Great Lakes were last revised in March 2016 and, by law, must be reviewed annually.

DATES:

Comments and related material must be submitted to the online docket via www.regulations.gov on or before December 19, 2016. Requests for a public meeting must be submitted by November 18, 2016.

ADDRESSES:

You may submit comments identified by docket number USCG-2016-0268 using the Federal eRulemaking Portal at http://www.regulations.gov. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this notice, and all public comments, are in our online docket at http://www.regulations.gov and can be viewed by following that Web site's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

We are not planning to hold a public meeting but will consider doing so if public comments indicate a meeting would be helpful. We would issue a separate Federal Register notice to announce the date, time, and location of such a meeting.

The legal basis of this rulemaking is the Great Lakes Pilotage Act of 1960 (“the Act”),1 which requires U.S. vessels operating “on register” 2 and foreign vessels to use U.S. or Canadian registered pilots while transiting the U.S. waters of the St. Lawrence Seaway and the Great Lakes system.3 For the U.S. registered Great Lakes pilots (“pilots”), the Act requires the Secretary to “prescribe by regulation rates and charges for pilotage services, giving consideration to the public interest and the costs of providing the services.” 4 The Act requires that rates be established or reviewed and adjusted each year, not later than March 1. The Act requires that base rates be established by a full ratemaking at least once every 5 years, and in years when base rates are not established, they must be reviewed and, if necessary, adjusted. The Secretary's duties and authority under the Act have been delegated to the Coast Guard.5

1 Public Law 86-555, 74 Stat. 259, as amended; currently codified as 46 U.S.C. Chapter 93.

2 “On register” means that the vessel's certificate of documentation has been endorsed with a registry endorsement, and therefore, may be employed in foreign trade or trade with Guam, American Samoa, Wake, Midway, or Kingman Reef. 46 U.S.C. 12105, 46 CFR 67.17.

3 46 U.S.C. 9302(a)(1).

4 46 U.S.C. 9303(f).

5 DHS Delegation No. 0170.1, para. II (92.f).

The purpose of this notice of proposed rulemaking (NPRM) is to propose new base pilotage rates and surcharges for training and propose new methodology in projecting pilotage rates. This includes proposals to adjust the surcharge provision to stop collecting funds once the assigned value has been recovered for the season; modify the regulations to review pilot compensation once every 10 years, with cost-of-living adjustments added annually between reviews; rename Return on Investment as Working Capital Fund to better clarify the intent of this step; and move the audit deadline from April to January of each year in order to capture expenses in the rate sooner and to eliminate 1 year from the current 3-year lag in expenses being recognized in the rate. The new methodology in proposing rates changes pilot demand from peak to seasonal.

In addition to these changes to the ratemaking process, the Coast Guard proposes adding pilots to support a mandatory change point on the Saint Lawrence River between Iroquois Lock and the area of Ogdensburg, NY. We further propose to amend the regulation regarding delays so that cancellation charges can be assessed in an appropriate manner. Finally, we are seeking public comment on how we should proceed with weighting factors.

IV. Background

The vessels affected by this NPRM are those engaged in foreign trade upon the U.S. waters of the Great Lakes. United States and Canadian “lakers,” which account for most commercial shipping on the Great Lakes, are not affected.6

6 46 U.S.C. 9302. A “laker” is a commercial cargo vessel especially designed for and generally limited to use on the Great Lakes.

The U.S. waters of the Great Lakes and the St. Lawrence Seaway are divided into three pilotage districts. Pilotage in each district is provided by an association certified by the Coast Guard Director of Great Lakes Pilotage (“the Director”) to operate a pilotage pool. The Coast Guard does not control the actual compensation that pilots receive. The actual compensation is determined by the district associations, each of which uses different compensation practices.

District One, consisting of Areas 1 and 2, includes all U.S. waters of the St. Lawrence River and Lake Ontario. District Two, consisting of Areas 4 and 5, includes all U.S. waters of Lake Erie, the Detroit River, Lake St. Clair, and the St. Clair River. District Three, consisting of Areas 6, 7, and 8, includes all U.S. waters of the St. Mary's River; Sault Ste. Marie Locks; and Lakes Huron, Michigan, and Superior. Area 3 is the Welland Canal, which is serviced exclusively by the Canadian Great Lakes Pilotage Authority (GLPA) and, accordingly, is not included in the United States pilotage rate structure.

Areas 1, 5, and 7 have been designated by Presidential Proclamation 7 to be waters in which pilots must, at all times, be fully engaged in the navigation of vessels in their charge. Areas 2, 4, 6, and 8 have not been so designated because they are open bodies of water. While working in those undesignated areas, pilots must “be on board and available to direct the navigation of the vessel at the discretion of and subject to the customary authority of the master.” 8

7 Presidential Proclamation 3385, Designation of restricted waters under the Great Lakes Pilotage Act of 1960, December 22, 1960.

8 46 U.S.C. 9302(a)(1)(B).

The Coast Guard is required to establish new pilotage rates by March 1 of each year, employing a full ratemaking at least once every 5 years and an annual review and adjustment in the intervening years.9 The Coast Guard will continue to review rates annually until we can stabilize the rates and ensure pilotage association revenues are in line with projections.

9 46 U.S.C. 9303(f).

In 2016, we revised our ratemaking methodology to improve the ratemaking process. Some of the changes proposed in this document further refine the 2016 methodology.

V. Discussion of Proposed Rate Changes

We propose new rates, and surcharges under 46 CFR 401.401, for 2017. This section discusses the proposed rates using the ratemaking steps provided in 46 CFR part 404. We reviewed the independent accountant's financial reports for each association's 2014 expenses and revenues. Those reports, which include pilot comments on draft versions and the accountant's response to those comments, appear in the docket.10 This year, we have reorganized the layout of this proposed rule to address the ratemaking steps for each pilotage district individually. This is only a formatting change to make the proposed rule easier to follow. We begin with District One, and some explanations in the section on District One will apply to similar changes in the other Districts.

Project next year's operating expenses, adjusting for inflation or deflation (§ 404.102). We based our inflation adjustments on the Bureau of Labor Statistics' (BLS) data from the Consumer Price Index for the Midwest Region of the United States,11 and reports from the Federal Reserve.12 The adjustments for District One are shown in Table 2.

11 Available at http://data.bls.gov/timeseries/CUUR0200SA0?data_tool=Xgtable

12 Available at https://www.federalreserve.gov/monetarypolicy/fomcprojtabl20160316.htm

Determine number of pilots needed (§ 404.103). To determine the number of pilots needed for 2017, we reviewed the historic number of annual assignments in each area going back to 2007. Our demand model from the 2016 final rule allows pilots 10 days of recuperative rest each month between mid-April and mid-November, in order to better mitigate long-term fatigue. A U.S. registered pilot may spend several days in various ports in between assignments, which is not considered recuperative rest.

In 2016, we examined peak staffing primarily through an analysis of the maximum number of trips needed through designated waters at the end of each season. We propose modifying our pilotage demand calculation to focus instead on the pilot work cycle, including elements such as travel, rest, pilot boat time, and other items in addition to time on the bridge of the ship, and the number of assignments we reasonably expect pilots to be able to complete during the 9-month shipping season instead of during peak pilotage demand. The rest standards apply from April 15 through November 15 of each shipping season, which are non-peak periods. Thus, of the 270 days of the shipping season,13 a pilot would be available for assignment on 200 of those days.14 During the opening and closing of the season, however, we expect all of the working pilots to be available. This is critical at the end of the season to prevent a ship from getting stuck in the system due to lock maintenance schedules. We invite comment on these assumptions and how this model might impact operations and the recruitment and retention of pilots.

13 Nine months per shipping season × 30 days per month.

14 Two-hundred and seventy days per season minus 70 days rest (7 non-peak months × 10 days rest per month).

Tables 3 through 7 examine our proposed staffing model. We begin our analysis with the pilot assignment cycle first discussed in the 2016 rulemaking.15 The pilot assignment cycle outlines the time needed to perform an assignment from beginning to end. This is shown in Table 3.

Average Through Transit Time *10.811.0Travel3.24.6Delay0.70.9Admin0.50.5Total Assignment15.217.0Mandatory Rest1010Pilot Cycle (hours/assignment)25.227.0* Updated since 2016 to reflect average through transit time based on current speed and other conditions as provided by pilot associations.

Using this data, we calculate the maximum number of assignments a pilot could conduct each year under perfect conditions with demand evenly distributed throughout the shipping season. This information follows in Table 4.

Our model uses this maximum figure to calculate a projected number of assignments for each pilot in the 2017 shipping season. At this time, we can neither track assignments electronically nor track individual pilot cycle times. Additionally, the projected number of assignments per pilot reflects only actual assignments and does not include time the pilot is standing by and waiting for the next assignment. This calculation is detailed in Table 5.

Table 5—Projected Assignments per Pilot in District OneAssignments per pilotDistrict OneArea 1

Next, we examine the historic number of assignments over the last nine shipping seasons, by Area, in District One. This will inform our final pilot strength calculation. The number of pilot assignments is detailed in Table 6.

Table 6—Historic Number of Assignments in District OneHistoric number of assignmentsDistrict OneArea 1Area 2200770855820086324802009361434201051859120115006342012479632201349059820146126372015593589Average Assignments544573

Finally, using the historic average number of assignments from the last nine shipping seasons (Table 6) and the projected assignments per pilot (Table 5), we are able to calculate the projected need for pilot strength for District One. This calculation is in Table 7. In all districts, when the calculation results in a fraction of a pilot, we round pilot numbers up to the nearest whole pilot. We do this to avoid shortening our demand calculation and also to compensate for the role of the district presidents as both working pilots and representatives of their associations. We believe the rounding is justified to meet the needs of the staffing model and also to ensure the presidents of the pilot associations are able to effectively engage in meetings and communications with stakeholders throughout the Great Lakes region and the Coast Guard.

Based on these tables, District One has a projected pilot need of 13 pilots for the 2017 season.

Proposed Mandatory Change Point Affecting Pilot Need

However, we also propose to add a mandatory change point in the vicinity of Iroquois Lock. In the 2016 NPRM, we proposed making Iroquois Lock a mandatory change point to enhance safety by mitigating fatigue on long pilotage runs. 80 FR 54487. However, we did not implement that proposal because the GLPA and Saint Lawrence Seaway Pilots Association informed us that they needed additional time to recruit, hire, and train additional pilots to implement this change. We propose adding the language, “The Saint Lawrence River between Iroquois Lock and the area of Ogdensburg, NY, at the opening of the 2017 shipping season,” to the list of mandatory change points in section 401.450. The transit between Snell Lock and Cape Vincent takes about 11 hours under ideal circumstances. We want to limit a U.S. registered pilot's assignment to 8 hours in designated waters in order to mitigate fatigue. Establishing this mandatory change point allows us to accomplish this goal.

Establishing this change point will increase the number of assignments and pilots needed in Area 1. Currently, about 40 percent of the assignments change at Iroquois Lock due to the night relief working rules or a slow moving vessel. We have historically counted this as one assignment even though two pilots are used to complete this assignment. For the purposes of calculating the number of additional assignments, we assume that 40 percent of trips currently switch pilots, while 60 percent will require a new pilot assignment. The historical average number of pilot assignments in District One, Area 1, is 544 per year (Table 6). If 60 percent of these will require an additional pilot assignment due to the new change point, 326 additional pilot assignments will be needed.16 From Table 5, pilots in this area average 95 assignments per season, resulting in the need for an additional 3.4 pilots to cover the additional assignments. Again, we round the calculated number of pilots needed to the next whole pilot to help ensure an adequate supply of pilots available for assignment.

16 We calculated 544 average assignments per year × .6 will require a new pilot assignment.

Based on these calculations, we propose four additional pilots to handle the increased number of assignments. The Saint Lawrence Seaway Pilots Association has communicated that it will have the necessary number of pilots trained at the beginning of the 2017 season. Therefore, we are proposing the addition of these pilots in the 2017 rulemaking, resulting in a total number of 17 pilots needed for District One (13 from Table 7 to handle existing demand, plus 4 to account for the Iroquois Lock change point).

We have coordinated with the Saint Lawrence Seaway Management Corporation (SLSMC), the Great Lakes Pilots Authority, and the Saint Lawrence Seaway Pilots Association, and concluded that the addition of the change point will not require capital expenses. The SLSMC will continue to allow the U.S. and Canadian registered pilots to use the Iroquois Lock for pilot changes. This avoids the need to purchase a new pilot boat and dock, as well as additional labor for support staff. If this changes, we will require District One to provide a plan for procuring a new pilot boat, dock, and additional support staff needed for this new change point, so that these costs can be included in a ratemaking.

We understand that District One plans to have all applicant pilots trained and working for the 2017 season. Therefore, Table 8 shows zero applicants, and consequently, no applicant surcharge for District One.

Table 8—Pilots Needed; Pilots Projected To Be WorkingDistrict OneNeeded pilots, period for which 2017 rates are in effect17Working pilots projected for 201717Applicant pilots for 20170

Determine target pilot compensation (§ 404.104). In the 2016 ratemaking, we attempted to align the compensation of U.S. registered pilots with the Canadian registered pilots of the GLPA and set a target compensation of $326,114. We are proposing to freeze target compensation for 2017 at the 2016 levels for the following reasons. First, the methodology used to align target compensation in the 2016 ratemaking used the foreign exchange rate between the Canadian and U.S. dollar to convert Canadian compensation to United States compensation. The exchange rate has changed substantially from 1.149CAD:1USD in 2014 to 1.329CAD:1USD in 2015.17 This is a change of nearly 20 percent. The volatility in exchange rates is dependent on factors external to the ratemaking, and we do not believe it is in the public interest to lower target pilot compensation by nearly 20 percent based on foreign exchange. Second, the system needs target pilot compensation stability in order to achieve and maintain workforce stability. Finally, the most challenging portion of this analysis is the conversion of Canadian benefits into roughly equivalent United States benefits. For example, the U.S. registered pilots invest their own money to own and operate the pilot associations, whereas the Canadian registered pilots do not. The Canadian registered pilots have a defined, government-backed pension, guaranteed time off, sick days, personal days, and medical benefits that require no out-of-pocket expenses. Our discussions with stakeholders, including the Canadian government, pilots, and industry, have highlighted the challenges of comparing benefits across international boundaries. We are not convinced that a single conversion from Canadian currency to United States currency properly accounts for the level of benefits provided to the Canadian registered pilots. We believe the most appropriate solution is to launch an independent, third-party study to examine pilot compensation and recommend a total compensation number. The Coast Guard is in the early stages of pursuing this study.

17 See https://www.irs.gov/individuals/international-taxpayers/yearly-average-currency-exchange-rates.

While we await the results of an independent third-party study, we propose maintaining the 2016 level for target pilot compensation for this ratemaking. The calculations of target pilot compensation for District One are displayed in Table 9.

Determine working capital fund (proposed § 404.105). We propose changing the term for this step from “Project return on investment” to “Determine working capital fund” based on several discussions with the shippers, ports, and agents. We agree with the shippers, ports, and agents that this is more than a return on the monies the pilots have invested in their infrastructure. The intent of this step is to provide the pilots with working capital for future expenses associated with capital improvements, technology investments, and future training needs, with the goal of eliminating the need for surcharges. Even though we propose changing the name of this step, we do not propose changing the calculation.

We calculate the working capital fund by multiplying the 2014 average rate of return for new issues of high-grade corporate securities and Total Expenses (Adjusted Operating Expenses from Step 2 plus Total Target Pilot Compensation from Step 4). We use the Moody's AAA bond rate information to determine the average annual rate of return for new issues of high-grade corporate securities. The 2014 average annual rate of return for new issues of high-grade corporate securities was 4.16 percent.18 The working capital fund calculation is shown in Table 10.

18 Based on Moody's AAA corporate bonds, which can be found at: http://research.stlouisfed.org/fred2/series/AAA/downloaddata?cid=119.

Make initial base rate calculations (proposed § 404.107). To make our initial base rate calculations, we first establish a multi-year base period from which we can draw available and reliable data on actual pilot hours worked in each district's designated and undesignated waters. For the 2017 rates, we propose using data covering 2007 through 2015. Table 12 shows calculations of the average number of bridge hours over the last 9 shipping seasons.

We are monitoring bridge hours and revenue projections for the season, and there is a great deal of variation in the system. Through the end of May 2016, projected bridge hours for the entire shipping season were up 45 percent in District One compared to the 9-year average, while revenue projection for the same period was only up 15 percent compared to our projected revenue needed. This suggested that the District One rate continued to under-generate needed revenue. However, by the end of July 2016, projected bridge hours for the entire shipping season were up 8.2 percent as compared to the 9-year average, and revenue projection was up 16 percent as compared to projected revenue needed, which suggests slight over-generation of revenue. We will continue to monitor traffic and revenue projections throughout the shipping season to see if any additional changes are needed.

Table 13 calculates new rates by dividing each association's projected needed revenue, from § 404.106, by the average hours shown in Table 12 and rounding to the nearest whole number.

Project next year's operating expenses, adjusting for inflation or deflation (§ 404.102). We based our inflation adjustments on BLS data from the Consumer Price Index for the Midwest Region of the United States,19 and reports from the Federal Reserve.20 The adjustments for District Two are shown in Table 15.

19 Available at http://data.bls.gov/timeseries/CUUR0200SA0?data_tool=Xgtable.

20 Available at https://www.federalreserve.gov/monetarypolicy/fomcprojtabl20160316.htm.

Determine number of pilots needed (§ 404.103). To determine the number of pilots needed for 2017 in District Two, we followed the same steps discussed earlier in this proposed rule for District One. The resulting calculations follow in Tables 16 through 20.

Average Through Transit Time *17.06.5Travel4.63.2Delay0.70.4Admin0.50.5Total Assignment22.810.6Mandatory Rest1010Pilot Cycle (hours/assignment)32.820.6* Updated since 2016 to reflect average through transit time based on current speed and other conditions as provided by pilot associations.Table 17—Calculation of Maximum Assignments for District TwoPilot assignmentsDistrict TwoArea 4Area 5Seasonal Availability Goal (hours)48004800Pilot Cycle (hours/assignment)32.820.6Max Assignments per Pilot146233Table 18—Projected Assignments per Pilot in District TwoAssignments per pilotDistrict TwoArea 4Area 5Max Assignments per Pilots146233Efficiency Adjustment *0.50.5Projected Assignments per Pilot73117* Recommended starting ratio per the 2013 bridge hour study (on page 23), available in the docket.Table 19—Historic Number of Assignments in District TwoHistoric number of assignmentsDistrict TwoArea 4Area 52007510866200844461620092904712010460821201133159820123516032013404693201462410432015576946Average Assignments443740Table 20—Projected Pilots Needed in District TwoPilots neededDistrict TwoArea 4Area 5Historic Average Assignments443740Projected Assignments per Pilot73117Projected Pilots Needed (unrounded)6.066.35Projected Pilots Needed (rounded)77

We round the calculated number of total pilots for District Two to the next whole pilot to help ensure that an adequate supply of pilots is available for assignment. Based on these tables, District Two has a projected need for 14 pilots for the 2017 season. At the beginning of the 2017 shipping season, they plan to have 13 working pilots and 2 applicants. We believe the second applicant is necessary to prepare for future retirements, given the extended training periods associated with new pilots. Currently, 4 of the pilots in District Two are over 62 years of age. These 4 pilots represent nearly 30 percent of the pilot strength in this association. Waiting until these pilots retire to replace them will result in significant delays. Therefore, we propose authorizing a surcharge in 2017, which we discuss in section “E. Surcharges” later in this preamble, to fund two applicant pilots in District Two.

Table 21—Pilots Needed; Pilots Projected To Be WorkingDistrict TwoNeeded pilots, period for which 2017 rates are in effect14Working pilots projected for 201713Applicant pilots for 20172

Determine target pilot compensation (§ 404.104). Similar to our discussion and proposal for District One, for the 2017 NPRM, we propose maintaining the 2016 compensation levels. Thus, target pilot compensation for 2017 would be $326,114. Total target pilot compensation for District Two is calculated in Table 22.

Determine working capital fund (proposed § 404.105). The 2014 average annual rate of return for new issues of high-grade corporate securities was 4.16 percent.21 We apply that rate to District Two's projected total operating and compensation expenses (from §§ 404.102 and 404.104) to determine the allowed working capital fund for the shipping season, as shown in Table 23.

21 Based on Moody's AAA corporate bonds, which can be found at: http://research.stlouisfed.org/fred2/series/AAA/downloaddata?cid=119.

Make initial base rate calculations (proposed § 404.107). To make our initial base rate calculations, we first establish a multi-year base period from which available and reliable data for actual pilot hours worked in each district's designated and undesignated waters can be drawn. For the 2017 rates, we propose using data covering 2007 through 2015. Table 25 calculates the average number of bridge hours over the last 9 shipping seasons.

We are monitoring bridge hours and revenue projections for the season, and there is a great deal of variation in the system. Through the end of May 2016, projected bridge hours for the entire shipping season were up 22 percent in District Two compared to the 9-year average, and revenue projection was up 17 percent compared to projected revenue needed. This suggested a robust correlation between traffic and revenue in District Two. However, by the end of July 2016, projected bridge hours were down 3.4 percent as compared to the 9-year average, while revenue projection was up 21 percent compared to projected revenue needed, which suggests over-generation of revenue. We will continue to monitor traffic and revenue projections throughout the shipping season to see if any additional changes are needed.

Table 26 calculates new rates by dividing District Two's projected needed revenue, from § 404.106, by the average hours shown in Table 25 and rounding to the nearest whole number.

Project next year's operating expenses, adjusting for inflation or deflation (§ 404.102). We based our inflation adjustments on BLS data from the Consumer Price Index for the Midwest Region of the United States,22 and reports from the Federal Reserve.23 The adjustments for District Three are shown in Table 28.

22 Available at http://data.bls.gov/timeseries/CUUR0200SA0?data_tool=Xgtable.

23 Available at https://www.federalreserve.gov/monetarypolicy/fomcprojtabl20160316.htm.

Determine number of pilots needed (§ 404.103). To determine the number of pilots needed for 2017 in District Three, we followed the same steps discussed earlier in this proposed rule for Districts One and Two. The resulting calculations follow in Tables 29 through 33.

Average Through Transit Time *22.57.121.6Travel2.43.63.7Delay10.33.3Admin0.50.50.5Total Assignment26.411.529.1Mandatory Rest101010Pilot Cycle (hours/assignment)36.421.539.1* Although transit times in Districts One and Two have been updated based on actual conditions, no similar change was required to reflect transit times in District Three.Table 30—Calculation of Maximum Assignments for District ThreePilot assignmentsDistrict ThreeArea 6Area 7Area 8Seasonal Availability Goal (hours)4,8004,8004,800Pilot Cycle (hours/assignment)36.421.539.1Max Assignments per Pilot132223123Table 31—Projected Assignments per Pilot in District ThreeAssignments per pilotDistrict ThreeArea 6Area 7Area 8Max Assignments per Pilots132223123Efficiency Adjustment *0.50.50.5Projected Assignments per Pilot6611261* Recommended starting ratio per the 2013 bridge hour study (on page 23), available in the docket.Table 32—Historic Number of Assignments in District ThreeHistoric number of assignmentsDistrict ThreeArea 6Area 7Area 8200768179447820084233092522009352231275201054735233820114602282232012436267243201346431532220147294265752015644412421Average Assignments526370347Table 33—Projected Pilots Needed in District ThreePilots neededDistrict ThreeArea 6Area 7Area 8Historic Average Assignments526370347Projected Assignments per Pilot6611261Projected Pilots Needed (unrounded)7.983.325.66Projected Pilots Needed (rounded)846

We round the calculated number of pilots needed by Area to the next whole pilot to help ensure an adequate supply of pilots are available for assignments. Based on these tables, District Three has a projected pilot need of 18 pilots for the 2017 season. However, at the beginning of the 2017 shipping season, they plan to have 15 working and registered pilots supplemented by 7 applicants. We believe the applicants are necessary to prepare for future retirements given the extended training periods associated with new pilots. Currently, 6 of the pilots who are trained or registered in District Three are over 61 years of age. These 6 pilots represent 30 percent of the current pilot strength for District Three, which is already less than the 18 pilots projected to be needed in 2017. If we wait until these pilots retire to begin replacing them, the system will experience significant delays due to a lack of available pilots. Therefore, we propose authorizing a surcharge, which we discuss in section E, below, to fund seven applicant pilots in District Three.

Table 34—Pilots Needed; Pilots Projected To Be WorkingDistrict ThreeNeeded pilots, period for which 2017 rates are in effect18Working pilots projected for 201715Applicant pilots for 20177

Determine target pilot compensation (§ 404.104). Similar to our discussion and proposal for Districts One and Two, we propose maintaining the 2016 compensation levels. Thus, target pilot compensation for 2017 would be $326,114. Total target pilot compensation for District Three is calculated in Table 35.

Determine working capital fund (proposed § 404.105). The 2014 average annual rate of return for new issues of high-grade corporate securities was 4.16 percent.24 We apply that rate to District Three's projected total operating and compensation expenses (from §§ 404.102 and 404.104) to determine the allowed working capital fund for the shipping season, as shown in Table 36.

24 Based on Moody's AAA corporate bonds, which can be found at: http://research.stlouisfed.org/fred2/series/AAA/downloaddata?cid=119.

Make initial base rate calculations (proposed § 404.107). To make our initial base rate calculations, we first establish a multi-year base period from which available and reliable data for actual pilot hours worked in each district's designated and undesignated waters can be drawn. For the 2017 rates, we propose using data covering 2007 through 2015. Table 38 calculates the average number of bridge hours over the last nine shipping seasons.

We are monitoring bridge hours and revenue projections for the season, and there is a great deal of variation in the system. Through the end of May 2016, projected bridge hours for the entire shipping season were down 10 percent in District Three as compared to the 9-year average, while revenue projection through May 2016 was up 9 percent compared to projected revenue needed. This suggested that the District Three rate was over-generating revenue. However, by the end of July 2016, projected bridge hours were up 23 percent as compared to the 9-year average, and revenue projection was up 19 percent as compared to projected revenue needed, which suggested a more robust correlation between traffic and revenue in District Three. We continue to monitor projections so that we can make changes if needed. In particular, we are considering removing the maximum ratio between designated and undesignated charges, which we established last year in § 404.107(b), if it appears to be artificially raising undesignated rates and lowering designated rates.

Table 39 calculates new rates by dividing District Three's projected needed revenue, from § 404.106, by the average hours shown in Table 38 and rounding to the nearest whole number.

Review and finalize rates (§ 404.108). In addition to the changes described earlier, we propose five additional changes for 2017 that will equally impact the pilot associations. First, we propose adding a requirement to the surcharge regulation in § 401.401. We propose that once a pilot association collects the amount of money allowable for recoupment, which is designated by the final rule, the pilot association's authorization to collect a surcharge for the remainder of that shipping season will terminate. This proposed change will prevent excess amounts from being recouped and should eliminate the need to make adjustments to the operating expenses for the following year. Turning to surcharges for 2017, we find that allowing associations to recoup necessary and reasonable training expenses, both to help achieve a full complement of needed pilots and to ensure skill maintenance and development for current pilots, will facilitate safe, efficient, and reliable pilotage, and is good cause for imposing a necessary and reasonable temporary surcharge, as authorized by 46 CFR 401.401.

In addition, we propose amending the cancellation charge provision in § 401.420(b) to ensure that it explicitly states that the minimum charge for a cancellation is 4 hours plus necessary and reasonable travel expenses for travel that occurs. Based on the feedback we received from the pilot associations, we believe the current language is not specific enough and will continue to cause confusion, as indicated by inquiries from both pilot associations and shipping agents. We view this charge as necessary to emphasize that pilots are a limited resource and encourage their efficient use. We are also removing “after that pilot has begun travelling to the designated pickup place” from § 401.420(b) to eliminate any confusion about the 4-hour minimum charge.

To expedite the recoupment of expenses, we also propose to adjust § 403.300(c) to require submission of an unqualified audit prepared in accordance with generally accepted accounting principles and all accompanying notes by January 31st of each year. This would require the pilot associations to complete their financial statements by January 24th in order to meet the January 31st deadline. Existing § 403.300(c) requires submission of an unqualified audit by April 1 of each year. Our goal is to allow our independent auditors to begin work much sooner and complete work on the third party audit in time for it to be used for the publication of the proposed rule that summer. This timeline would remove 1 year from the current 3-year gap between the actual expenses and their recoupment in the rate. We request comments regarding the feasibility of completing the required audits by January 31, and if it is not feasible, an explanation as to why and what other date would be appropriate.

We also propose the addition of new language in § 404.104 that would allow the Director to set compensation for a 10-year period to a compensation benchmark. The compensation benchmark would be based on the most relevant available non-proprietary information such as wage and benefit information from other pilotage groups. In the years in which a compensation benchmark is not set, target pilot compensation will be adjusted for inflation by using the CPI for the Midwest region or by a pre-determined amount that would be published prior to use. We believe this will promote target compensation stability and rate predictability.

The proposed changes to §§ 403.300(c) and 404.104 should assist the pilot associations with recruitment and retention and help the various stakeholders forecast budgets and pricing. These changes would apply only to the calculation of target pilot compensation; we do not propose any changes to the formula in which we use target pilot compensation to calculate the rate.

Finally, we seek public comment on how we should handle weighting factors in 46 CFR 401.400, which outlines the calculations for determining the weighting factors for a vessel subject to compulsory pilotage. This calculation determines which multiplication factor will be applied to the pilotage fees. We are not proposing any action in this proposed rule because we do not have sufficient data to make an informed decision.

The first option is to maintain the status quo. This would maintain the current weighting factors and continue to leave them out of the ratemaking calculation.

The second option for weighting factors is to remove them completely from the regulations and charge every vessel equally for pilotage service. This aligns with the current compensation model that a pilot should be compensated equally for their expertise across all areas of the Great Lakes. The ship's dimensions do not impact the experience and skill level of the pilot providing the service.

The third option is to incorporate weighting factors into the rulemaking through an additional step that examines and projects their impact on the revenues of the pilot associations. This might enable us to better forecast revenue, but it would add another variable to the projections in the rate methodology.

We request public comment specifically on which of these three options should be implemented for future ratemakings; in your comment, please explain why the option should be implemented.

E. Surcharges

Turning to surcharges for 2017, we find that allowing associations to recoup necessary and reasonable training expenses, both to help achieve a full complement of needed pilots and to ensure skill maintenance and development for current pilots, will facilitate safe, efficient, and reliable pilotage, and is good cause for imposing a necessary and reasonable temporary surcharge, as authorized by 46 CFR 401.401. For 2017, we anticipate that there will be two applicant pilots in District Two, and seven applicant pilots in District Three. Based on historic pilot costs, the stipend, per diem, and training costs for each applicant pilot are approximately $150,000 per shipping season. Thus, we estimate that the training expenses that each association will incur will be approximately $300,000 in District Two and $1,050,000 in District Three. Table 40 derives the proposed percentage surcharge for each district by comparing this estimate to each district's projected needed revenue.

These surcharges would only be collected until the target amount is reached. This should eliminate the need to make adjustments to the operating expenses for the following year. We will ensure that these expenses are not included in future rulemakings in order to avoid double billing.

VI. Regulatory Analyses

We developed this proposed rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on these statutes or Executive orders.

A. Regulatory Planning and Review

Executive Orders 13563 and 12866 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive effects, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

This proposed rule has not been designated a “significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, this proposed rule has not been reviewed by the Office of Management and Budget (OMB).

We developed an analysis of the costs and benefits of the proposed rule to ascertain its probable impacts on industry. We consider all estimates and analysis in this Regulatory Analysis (RA) to be subject to change in consideration of public comments.

Table 41 summarizes the regulatory changes that are expected to have no costs, and any qualitative benefits associated with them. The table also includes proposed changes that affect portions of the methodology for calculating the proposed base pilotage rates. While these proposed changes affect the calculation of the rate, the costs of these changes are captured in the changes to the total revenue as a result of the proposed rate change (summarized in Table 42).

Table 41—Regulatory Changes With No Cost or Costs Captured in the Proposed Rate ChangeProposed changesDescriptionBasis for no costsBenefitsMandatory change point on the Saint Lawrence River between Iroquois Lock and the area of Ogdensburg, NYPropose a mandatory change point on the Saint Lawrence River between Iroquois Lock and the area of Ogdensburg, NY that would become effective at the beginning of the 2017 shipping seasonThe addition of the change point will not require capital expenses. The only cost is for the new pilots, who are accounted for in the base pilotage rates and training surcharges (Table 43)Staffing additional pilots will help meet the increased demand for pilots to handle the additional assignments anticipated to be caused by the new change point. Additional pilots due to this change point should also serve to mitigate any potential delays and any potential fatigue that would occur from high pilotage demand without them.Demand modelDetermine pilot demand using seasonal demand instead of peak demandPilot staffing costs are accounted for in the base pilotage rates (Table 43)More accurate estimate of the number of assignments we reasonably expect pilots to be able to complete during the 9-month shipping season instead of during peak pilotage demand.Cancellation chargesPropose amending the cancellation charge provision in § 401.120(b) to ensure it explicitly states that the minimum charge for a cancellation is 4 hours plus necessary and reasonable travel expenses for that travel that occursClarification of existing text and current practice—Clarifies the current language to eliminate any potential confusion on the minimum charge for cancellations.

—Clarification of the minimum charge ensures the recognition of pilots as a limited resource and encourages efficient use.

Surcharge provisionPropose adding a requirement to the surcharge regulation in § 401.401 to stop collecting funds once the assigned value has been recovered for the seasonEnsures the goal surcharge amount built into the year's rulemaking will not be surpassed, and prevents additional costs on industryPrevents excess amounts from being recouped from industry via the following year's rule.Audit deadlinePropose to adjust § 403.300(c) to move the audit deadline from April 1 to January 31 of each yearAdjusts the deadline for audit submission, but does not add additional workAllows independent auditors to begin work sooner and complete the audit in time for the proposed rule. This would eliminate 1 year from the current 3-year lag in expenses being recognized in the rate.Rename Return on InvestmentPropose renaming Return on Investment as Working Capital FundClarifies the intent of the fund but does not change the method of calculation. Costs are included in the total revenuesClarifies the intent of this fund.Set Pilot compensation for a 10-year periodPropose the addition of new language in § 404.104 that would allow the Director to set compensation for a 10-year period to a compensation benchmarkPilot staffing costs are accounted for in the base pilotage ratesPromotes target compensation stability and rate predictability.

The following table summarizes the affected population, costs, and benefits of the regulatory requirements that are expected to have costs associated with them.

Table 42—Regulatory Economic Impacts of Rate ChangeProposed changeDescriptionAffected populationCostsBenefitsRate ChangesUnder the Great Lakes Pilotage Act of 1960, the Coast Guard is required to review and adjust base pilotage rates annuallyOwners and operators of 230 vessels journeying the Great Lakes system annually$2,664,574—New rates cover an association's necessary and reasonable operating expenses.

The Coast Guard is required to review and adjust pilotage rates on the Great Lakes annually. See Parts III and IV of this preamble for detailed discussions of the Coast Guard's legal basis and purpose for this rulemaking and for background information on Great Lakes pilotage ratemaking. Based on our annual review for this proposed rulemaking, we are adjusting the pilotage rates for the 2017 shipping season to generate for each district sufficient revenues to reimburse its necessary and reasonable operating expenses, fairly compensate trained and rested pilots, and provide an appropriate working capital fund to use for improvements. The rate changes in this proposed rule would, if codified, lead to an increase in the cost per unit of service to shippers in all three districts, and result in an estimated annual cost increase to shippers.

In addition to the increase in payments that would be incurred by shippers in all three districts from the previous year as a result of the proposed rate changes, we propose authorizing a temporary surcharge to allow the pilotage associations to recover training expenses that would be incurred in 2017. For 2017, we anticipate that there will be no applicant pilots in District One, two applicant pilots in District Two, and seven applicant pilots in District Three. With a training cost of $150,000 per pilot, we estimate that Districts Two and Three will incur $300,000 and $1,050,000 in training expenses, respectively. These temporary surcharges would generate a combined $1,350,000 in revenue for the pilotage associations. Therefore, after accounting for the implementation of the temporary surcharges across all three districts, the payments made by shippers during the 2017 shipping season are estimated to be approximately $2,664,574 more than the payments that were estimated in 2016 (Table 43).25

25 Total payments across all three districts are equal to the increase in payments incurred by shippers as a result of the rate changes plus the temporary surcharges applied to traffic in Districts One, Two, and Three.

A draft regulatory analysis follows.

The purpose of this rulemaking is to propose new base pilotage rates and surcharges for training. The last full ratemaking was concluded in 2016.

Affected Population

The shippers affected by these rate changes are those owners and operators of domestic vessels operating on register (employed in foreign trade) and owners and operators of foreign vessels on routes within the Great Lakes system. These owners and operators must have pilots or pilotage service as required by 46 U.S.C. 9302. There is no minimum tonnage limit or exemption for these vessels. The statute applies only to commercial vessels and not to recreational vessels. United States-flagged vessels not operating on register and Canadian “lakers,” which account for most commercial shipping on the Great Lakes, are not required to have pilots by 46 U.S.C. 9302. However, these U.S.- and Canadian-flagged lakers may voluntarily choose to have a pilot.

We used 2013-2015 billing information from the GLPMS to estimate the average annual number of vessels affected by the rate adjustment. The GLPMS tracks data related to managing and coordinating the dispatch of pilots on the Great Lakes and billing in accordance with the services. Using that period, we found that a total of 407 unique vessels used pilotage services over the years 2013 through 2015. These vessels had a pilot dispatched to the vessel and billing information was recorded in the GLPMS. The number of invoices per vessel ranged from a minimum of 1 invoice per year to a maximum of 65 invoices per year. Of these vessels, 383 were foreign-flagged vessels and 24 were U.S.-flagged. The U.S.-flagged vessels are not required to have a pilot per 46 U.S.C. 9302, but they can voluntarily choose to have a pilot. U.S.-flagged vessels may opt to have a pilot for varying reasons such as unfamiliarity with designated waters and ports, or for insurance purposes.

Vessel traffic is affected by numerous factors and varies from year to year. Therefore, rather than the total number of vessels over the time period, an average of the unique vessels using pilotage services from 2013 through 2015 is the best representation of vessels estimated to be affected by this rule's proposed rate. From the years 2013-2015, an average of 230 vessels used pilotage services annually.26 On average, 219 of these vessels are foreign-flagged vessels and 11 are U.S.-flagged vessels that voluntarily opt into the pilotage service.

26 Some vessels entered the Great Lakes multiple years, affecting the average number of unique vessels utilizing pilotage services in any given year.

Costs

The rate changes resulting from the new methodology would generate costs on industry in the form of higher payments for shippers. We calculate the cost in two ways in this RA, as the total cost to shippers and as a percentage of vessel operating costs.

Total Cost to Shippers

We estimate the effect of the rate changes on shippers by comparing the total projected revenues needed to cover costs in 2016 with the total projected revenues to cover costs in 2017, including any temporary surcharges authorized by the Coast Guard. The Coast Guard sets pilotage rates so that the pilot associations receive enough revenue to cover their necessary and reasonable expenses. The shippers pay these rates when they have a pilot as required by 46 U.S.C. 9302. Therefore, the aggregate payments of the shippers to the pilot associations are equal to the projected necessary revenues for the pilot associations. The revenues each year represent the total costs that shippers must pay for pilotage services, and the change in the revenues from the previous year is the additional cost to shippers from this proposed rulemaking.

The effect of the rate changes on shippers is estimated from the District pilotage projected revenues and the proposed surcharges described in Section V of this preamble. We estimate that for the 2017 shipping season, the projected revenue needed for all three Districts is $20,418,252. Temporary surcharges on traffic in District Two and District Three would be applied for the duration of the 2017 season in order for the pilotage associations to recover training expenses incurred for applicant pilots. We estimate that the pilotage associations require an additional $300,000 and $1,050,000 in revenue for applicant training expenses in Districts Two and Three, respectively. This is an additional cost to shippers of $1,350,000 during the 2017 shipping season. Adding the projected revenue to the proposed surcharges, we estimate the pilotage associations' total projected needed revenue for 2017 would be $21,768,252. The 2017 projected revenues for the districts are from Tables 11, 24, and 37 of this preamble. To estimate the additional cost to shippers from this proposed rule, we compare the 2017 total projected revenues to the 2016 projected revenues. Because the Coast Guard must review and prescribe rates for the Great Lakes Pilotage annually, the effects are estimated as a single year cost rather than annualized over a 10-year period. In the 2016 rulemaking,27 we estimated the total projected revenue needed for 2016, including surcharges, is $19,103,678. This is the best approximation of 2016 revenues as, at the time of this publication, we do not have enough audited data available for the 2016 shipping season to revise these projections. Table 43 shows the revenue projections for 2016 and 2017 and details the additional cost increases to shippers by area and district as a result of the rate changes and temporary surcharges on traffic in Districts One, Two, and Three.

Table 43—Effect of the Proposed Rule by Area and District [$U.S.; Non-discounted]AreaRevenue needed in 20162016

Temporary

surcharge

Total 2016

Projected

revenue

Revenue needed in 20172017

Temporary

surcharge

Total 2017

Projected

revenue

Additional costs of this proposed ruleTotal, District One$5,354,945$450,000$5,804,945$7,001,953$0$7,001,953$1,197,008Total, District Two5,629,641300,0005,929,6416,263,404300,0006,563,404633,763Total, District Three6,469,092900,0007,369,0927,152,8951,050,0008,202,895833,803System Total17,453,6781,650,00019,103,67820,418,2521,350,00021,768,2522,664,574* Values may not sum due to rounding.

The resulting difference between the projected revenue in 2016 and the projected revenue in 2017 is the annual change in payments from shippers to pilots as a result of the rate change imposed by this proposed rule. The effect of the rate change in this proposed rule on shippers varies by area and district. The rate changes, after taking into account the increase in pilotage rates and the addition of temporary surcharges, would lead to affected shippers operating in District One, District Two, and District Three experiencing an increase in payments of $1,197,008, $633,763, and $833,803, respectively, from the previous year. The overall adjustment in payments would be an increase in payments by shippers of approximately $2,664,574 across all three districts (a 14 percent increase over 2016). Because the Coast Guard must review and prescribe rates for Great Lakes Pilotage annually, the effects are estimated as single year costs rather than annualized over a 10-year period.

Table 44 shows the difference in revenue by component from 2016 to 2017.28 Although per pilot compensation is unchanged from the 2016 final rule, the majority of the increase in revenue is due to the addition of 8 pilots that were authorized in the 2016 rule. These eight pilots are currently training this year and will become full-time working pilots at the beginning of the 2017 shipping season. These pilots will be compensated at the target compensation established in the 2016 final rule ($326,114 per pilot). The addition of these pilots to full working status accounts for $2,608,913 of the increase. The remaining amount is attributed to inflation of operating expenses, working capital fund, and differences in the surcharges from 2016.

28 The 2016 projected revenues are from the 2016 rulemaking, 81 FR 11934, Figures 24 and 28. The 2017 projected revenues are from Tables 11, 24, 37, and 40 of this NPRM.

Table 44—Difference in Revenue by ComponentRevenue componentRevenue needed in 2016Revenue needed in 2017Difference

To estimate the impact of U.S. pilotage costs on the foreign vessels affected by the rate adjustment, we looked at the pilotage costs as a percentage of a vessel's costs for an entire voyage. The part of the trip on the Great Lakes using a pilot is only a portion of the whole trip. The affected vessels are often traveling from a foreign port, and the days without a pilot on the total trip often exceed the days a pilot is needed.

To estimate this impact, we used 2013-2015 vessel arrival data from the Coast Guard's Ship Arrival Notification System and pilotage billing data from the GLPMS. A random sample of 50 arrivals was taken from GLPMS data. To estimate the impact of pilotage costs on the costs of an entire trip, we estimated the length of each one way trip. We used the vessel name and the date of the arrival to find the last port of call before entering the Great Lakes system. The date of the departure from this port was used as the start date of the trip. To find the end date of the trip we used GLPMS data to find all the pilotage charges associated with this vessel during this trip in the Great Lakes system. The end date of the one way trip was taken as the last pilotage charge before beginning the trip to exit the system. We estimated the total operating cost by multiplying the number of days for each by the 2015 average daily operating cost and added this to the total pilotage costs from GLPMS for each trip. In 2015 the average daily operating costs (excluding fixed costs) for Great Lakes bulkers and tankers ranged roughly from $5,191 to $7,879.29 The total pilotage charges for each trip were updated to the 2016 rates using the average rate increases in the Great Lakes Pilotage Rates 2013-2016 Annual Review and Adjustments final rules.30 The total updated pilotage charges for each trip were then divided by the total operating cost of the trip. We found that for a vessel's one-way trips, the U.S. pilotage costs could account for approximately 16.99 percent 31 of the total operating costs for a foreign vessel's voyage using 2016 rates.

29“Ship operating costs: Current and future trends,” Richard Grenier, Moore Stephens LLP, December 2015. The 2015 weighted average operating cost is estimated at $5,191 for a handysize bulker, $5,771 for a handymax bulker, and $7,879 for a product tanker. These costs include only the costs of operating and do not include any fixed costs of the vessels (such as amortization of vessel construction costs). The operating costs include crew wages, provisions, other crew costs, lubricating oils and store costs, spares, repair and maintenance, P&I insurance, marine insurance, registration costs, management fees, and sundry expenses.

30 The average percentage changes in the rates for 2013-2016, were 1.87%, 2.5%, 10%, and 12%, respectively.

31 For the random sample of 50 arrivals, the average of the pilotage costs as a percentage of the total operating costs was 16.9%. The percentages ranged from a low of 3.2% to a high of 35.2%.

We also estimated the impact of the rate increase in this proposed rule. We took the same 50 trips and updated the pilotage costs to the proposed 2017 rates (average increase of 17 percent). With this proposed rule's rates for 2017, pilotage costs are estimated to account for 19.11 percent of total operating costs, or a 2.2 percentage point increase 32 over the current cost. The total operating costs do not include the fixed costs of the vessels. If these costs are included in the total costs, the pilotage rates as a percentage of total costs would be lower.

32 19.1% of total operating costs in 2017—16.9% of total operating costs in 2016 = 2.2% incremental increase of pilotage costs as a percentage of total operating costs.

Benefits

This proposed rule would allow the Coast Guard to meet the requirements in 46 U.S.C. 9303 to review the rates for pilotage services on the Great Lakes. The rate changes would promote safe, efficient, and reliable pilotage service on the Great Lakes by ensuring rates cover an association's operating expenses; provide fair pilot compensation, adequate training, and sufficient rest periods for pilots; and ensures the association makes enough money to fund future improvements. The rate changes will also help recruit and retain pilots, which will ensure a sufficient number of pilots to meet peak shipping demand, which would help reduce delays caused by pilot shortages.

The proposed amendment of the cancellation charge in § 401.120(b) would prevent confusion and help ensure that it explicitly states that the minimum charge for a cancellation is 4 hours. The proposed limitation to the surcharge regulation in § 401.401 would prevent excess amounts from being recouped via the following year's rule. The proposed adjustment to § 403.300(c) to require submission of an unqualified audit by January 31st of each year would allow our independent auditors to begin work much sooner and complete work on the third party audit in time to be used for the publication of the proposed rule that summer. This timeline would remove 1 year from the current 3-year gap between the actual expenses and their recoupment in the rate. The proposed changes to § 404.104 will promote target compensation stability and rate predictability. The proposed changes to §§ 403.300(c) and 404.104 should assist the pilot associations with recruitment and retention and help the various stakeholders forecast budgets and pricing.

B. Small Entities

Under the Regulatory Flexibility Act, 5 U.S.C. 601-612, we have considered whether this proposed rule would have a significant economic effect on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000 people.

For the proposed rule, we reviewed recent company size and ownership data for the vessels identified in GLPMS and we reviewed business revenue and size data provided by publicly available sources such as MANTA 33 and ReferenceUSA.34 As described in Section VI.A of this preamble, Regulatory Planning and Review, we found that a total of 407 unique vessels used pilotage services over the years 2013-2015. These vessels are owned by 119 entities. We found that of the 119 entities that own or operate vessels engaged in trade on the Great Lakes affected by this proposed rule, 104 are foreign entities that operate primarily outside of the United States. The remaining 15 entities are U.S. entities. We compared the revenue and employee data found in the company search to the Small Business Administration's (SBA) Table of Small Business Size Standards 35 to determine how many of these companies are small entities. Table 45 shows the NAICS codes of the U.S. entities and the small entity standard size established by the Small Business Administration.

33 See http://www.manta.com/.

34 See http://resource.referenceusa.com/.

35 Source: https://www.sba.gov/contracting/getting-started-contractor/make-sure-you-meet-sba-size-standards/table-small-business-size-standards. SBA has established a Table of Small Business Size Standards, which is matched to NAICS industries. A size standard, which is usually stated in number of employees or average annual receipts (“revenues”), represents the largest size that a business (including its subsidiaries and affiliates) may be considered in order to remain classified as a small business for SBA and Federal contracting programs.

The entities all exceed the SBA's small business standards for small businesses. Further, these U.S. entities operate U.S.-flagged vessels and are not required to have pilots as required by 46 U.S.C. 9302.

In addition to the owners and operators of vessels affected by this proposed rule, there are three U.S. entities affected by the proposed rule that receive revenue from pilotage services. These are the three pilot associations that provide and manage pilotage services within the Great Lakes districts. Two of the associations operate as partnerships and one operates as a corporation. These associations are designated with the same NAICS industry classification and small-entity size standards described above, but they have fewer than 500 employees; combined, they have approximately 65 total employees. We expect no adverse effect to these entities from this proposed rule because all associations receive enough revenue to balance the projected expenses associated with the projected number of bridge hours and pilots.

We did not find any small not-for-profit organizations that are independently owned and operated and are not dominant in their fields. We did not find any small governmental jurisdictions with populations of fewer than 50,000 people. Based on this analysis, we found this proposed rulemaking, if promulgated, would not affect a substantial number of small entities.

Therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this proposed rule would have a significant economic impact on it, please submit a comment to the Docket Management Facility at the address under ADDRESSES. In your comment, explain why you think it qualifies, as well as how and to what degree this proposed rule would economically affect it.

C. Assistance for Small Entities

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121, we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the proposed rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please consult Mr. Todd Haviland, Director, Great Lakes Pilotage, Commandant (CG-WWM-2), Coast Guard; telephone 202-372-2037, email Todd.A.Haviland@uscg.mil, or fax 202-372-1914. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

D. Collection of Information

This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). This proposed rule would not change the burden in the collection currently approved by OMB under OMB Control Number 1625-0086, Great Lakes Pilotage Methodology.

E. Federalism

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132. Our analysis follows.

Congress directed the Coast Guard to establish “rates and charges for pilotage services.” 46 U.S.C. 9303(f). This regulation is issued pursuant to that statute and is preemptive of state law as specified in 46 U.S.C. 9306. Under 46 U.S.C. 9306, a “State or political subdivision of a State may not regulate or impose any requirement on pilotage on the Great Lakes.” As a result, States or local governments are expressly prohibited from regulating within this category. Therefore, the rule is consistent with the principles of federalism and preemption requirements in Executive Order 13132.

While it is well settled that States may not regulate in categories in which Congress intended the Coast Guard to be the sole source of a vessel's obligations, the Coast Guard recognizes the key role that State and local governments may have in making regulatory determinations. Additionally, for rules with implications and preemptive effect, Executive Order 13132 specifically directs agencies to consult with State and local governments during the rulemaking process. If you believe this rule has implications for federalism under Executive Order 13132, please contact the person listed in the FOR FURTHER INFORMATION section of this preamble.

F. Unfunded Mandates Reform Act

The Unfunded Mandates Reform Act of 1995, (2 U.S.C. 1531-1538), requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or Tribal Government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we discuss the effects of this proposed rule elsewhere in this preamble.

G. Taking of Private Property

This proposed rule would not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

We have analyzed this proposed rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This proposed rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.

J. Indian Tribal Governments

This proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

K. Energy Effects

We have analyzed this proposed rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that Executive Order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

L. Technical Standards

The National Technology Transfer and Advancement Act (15 U.S.C. 272, note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the OMB, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

M. Environment

We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. A preliminary environmental analysis checklist supporting this determination is available in the docket where indicated under the “Public Participation and Request for Comments” section of this preamble. This proposed rule is categorically excluded under section 2.B.2, and figure 2-1, paragraph 34(a) of the Instruction. Paragraph 34(a) pertains to minor regulatory changes that are editorial or procedural in nature. This proposed rule adjusts rates in accordance with applicable statutory and regulatory mandates. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

To facilitate safe, efficient, and reliable pilotage, and for good cause, the Director may authorize surcharges on any rate or charge authorized by this subpart. Surcharges must be proposed for prior public comment and may not be authorized for more than 1 year. Once the approved amount has been received, the pilot association is not authorized to collect any additional funds under the surcharge authority and must cease such collections for the remainder of that shipping season.

(b) When an order for a U.S. pilot's service is cancelled, the vessel can be charged for the pilot's reasonable travel expenses for travel that occurred to and from the pilot's base, and the greater of—

(1) Four hours; or

(2) The time of cancellation and the time of the pilot's scheduled arrival, or the pilot's reporting for duty as ordered, whichever is later.

(c) By January 24 of each year, each association must obtain an unqualified audit report for the preceding year that is audited and prepared in accordance with generally accepted accounting principles by an independent certified public accountant. Each association must electronically submit that report with any associated settlement statements and all accompanying notes to the Director by January 31.

PART 404—GREAT LAKES PILOTAGE RATEMAKING8. The authority citation for part 404 continues to read as follows:Authority:

9. Amend § 404.103 as follows:a. In paragraph (a), following the words “dividing each area's” remove the word “peak” and add, in its place, the word “seasonal”; andb. Revise paragraph (b) to read as follows:§ 404.103 Ratemaking step 3: Determine number of pilots needed.

(b) Pilotage demand and the base seasonal work standard are based on available and reliable data, as so deemed by the Director, for a multi-year base period. The multi-year period is the 10 most recent full shipping seasons, and the data source is a system approved under 46 CFR 403.300. Where such data are not available or reliable, the Director also may use data, from additional past full shipping seasons or other sources, that the Director determines to be available and reliable.

At least once every 10 years, the Director will set a base target pilot compensation benchmark using the most relevant available non-proprietary information. In years in which a base compensation benchmark is not set, target pilot compensation will be adjusted for inflation using the CPI for the Midwest region or a published predetermined amount. The Director determines each pilotage association's total target pilot compensation by multiplying individual target pilot compensation by the number of pilots projected under § 404.103(d).

The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Comments regarding this information collection received by November 18, 2016 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to: OIRA_Submission@OMB.EOP.GOV or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Copies of the submission(s) may be obtained by calling (202) 720-8958.

An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

Animal and Plant Health Inspection Service

Title: Specimen Submission.

OMB Control Number: 0579-0090.

Summary of Collection: The Animal Health Protection Act of 2002 (AHPA) is the primary Federal law governing the protection of animal health. The law gives the Secretary of Agriculture broad authority to detect, control, or eradicate pests or diseases of livestock or poultry. Disease prevention is the most effective method for maintaining a healthy animal population and for enhancing the United States' ability to globally compete in the trade of animals and animal products. VS Forms 10-4 and 10-4A, Specimen Submission are critical components of APHIS' disease surveillance mission. They are used routinely when specimens (such as blood, milk, tissue, or urine) from any animal (including cattle, swine, sheep, goats, horses, and poultry) are submitted to APHIS' National Veterinary Services Laboratories (NVSL) for disease testing. VS Form 5-38, Parasite Submission form, is completed by State veterinarians or other State representatives, accredited veterinarians, private laboratories, research institutions, and owners or producer.

Need and Use of the Information: Using APHIS form VS 10-4, State or Federal veterinarians, accredited veterinarians, or other State and Federal representatives will document the collection and submission of specimens for laboratory analysis. The form identifies the individual animal from which the specimen is taken as well as the animal's herd or flock; the type of specimen submitted, and the purpose of submitting the specimen. The National Tick Surveillance Program is based on the information submitted on VS Form 5-38, in addition to critical surveillance information needed for the Cattle Fever Tick Eradication Program. This information identifies the individual submitting the tick samples. Without the information APHIS would not have the critical information necessary to effectively operate a disease surveillance program.

Description of Respondents: State, Local or Tribal Government; Business or other for-profit.

Harrisburg Hilton and Towers, One North Second Street, Harrisburg, PA 17101.

STATUS:

The meeting will be open to the public.

MATTERS TO BE CONSIDERED:

Portions Open to the Public: The primary purpose of this meeting is to (1) Review the independent auditors' report of the Commission's financial statements for fiscal year 2015-2016; (2) Review the Low-Level Radioactive Waste (LLRW) generation information for 2015; (3) Consider a proposed budget for fiscal year 2017-2018; (4) Review recent regional and national developments regarding LLRW management and disposal; and (5) Elect the Commission's Officers.

Portions Closed to the Public: Executive Session, if deemed necessary, will be announced at the meeting.

The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

DATES:

To ensure consideration, written comments must be submitted on or before December 19, 2016.

During the years preceding the 2020 Census, the Census Bureau will pursue its commitment to reduce the costs of conducting a decennial census, while maintaining our commitment to quality. In the 2018 Fiscal Year, the Census Bureau will be performing a 2018 End-to-End Census Test. This last major test before the 2020 Census has the stated purpose (1) to test and validate 2020 Census operations, procedures, systems, and field infrastructure together to ensure proper integration and conformance with functional and non-functional requirements, and (2) to produce a prototype of geographic and data products.

The Address Canvassing operation, beginning in the summer of 2017, is the first operation in the 2018 End-to-End Census Test. The purpose of the Address Canvassing operation is (1) to deliver a complete and accurate address list and spatial database for enumeration and tabulation, and (2) to determine the type and address characteristics for each living quarter.

The following objectives are crucial to a successful Address Canvassing operation:

For the 2010 Census, Address Canvassing field staff, referred to as listers, traversed almost every block in the nation to compare what they observed on the ground to the contents of the Census Bureau's address list. Listers verified or corrected addresses that were on the list, added new addresses to the list, and deleted addresses that no longer existed. Listers also collected map spot locations (i.e., Global Positioning System coordinates) for each structure and added new streets.

In addition to Address Canvassing, the Census Bureau conducted the Group Quarters Validation (GQV) operation after the Address Canvassing operation and prior to enumeration for the 2010 Census. The purpose of the GQV operation was to improve the Group Quarters (GQ) frame. A GQ is a place where people live or stay, in a group living arrangement that is owned or managed by an entity or organization providing housing and/or services for the residents. This is not a typical household-type living arrangement, and residency is commonly restricted to those receiving specific services. Types of GQs include such places as college residence halls, residential treatment centers, skilled-nursing facilities, group homes, military barracks, correctional facilities, and workers' dormitories.

For the 2010 Census GQV operation, field staff visited a specific address to determine if it was a GQ, housing unit, transitory location (TL), a non-residential unit, or if it was nonexistent. If the address was a GQ or TL, the lister collected additional information needed for subsequent enumeration operations such as contact name. In support of a more efficient census design strategy, the 2020 Census will not conduct a separate operation to validate GQ information. Instead, the 2020 Census will validate GQ information during the Address Canvassing operation. This includes the collection of a contact name and phone number, as well as data about the type of GQ and the number of potential residents, which will be needed in enumeration operations during the census. The Address Canvassing Operation component of the 2018 End-to-End Census Test will be a test of the Address Canvassing field procedures planned for the 2020 Census Address Canvassing, as well as a validation study of the In-Office Address Canvassing that is planned. These processes are described in more detail below.

2020 Census Address Canvassing: In-Office Address Canvassing

In-Office Address Canvassing is the process of using empirical geographic evidence (e.g., imagery, comparison of the Census Bureau's address list to partner-provided lists) to assess the current address list and make changes where necessary. This component detects and captures change from high quality administrative and third-party data, reducing the In-Field Address Canvassing workload.

In-Office Address Canvassing starts with Interactive Review (IR), which is an imagery-based review to assess the extent to which the number of addresses—both housing units and GQs—in the census address list are consistent with the number of addresses visible in current imagery. It also assesses the changes between the current imagery and an older vintage of imagery (around the time of 2010 Census Address Canvassing).

Results from IR inform the Active Block Resolution (ABR) process, which seeks to research and update areas identified with growth, decline, undercoverage of addresses, or overcoverage of addresses from the comparison of the two different vintages of imagery and counts of addresses in the Master Address File (MAF) maintained by the Census Bureau. In addition to using the results from IR, the ABR process uses other data sources to resolve the identified issues in the office and to update the MAF rather than sending these areas to In-Field Address Canvassing. The other data sources include local Geographic Information Systems (GIS) viewers available online, parcel data, local files acquired through the U.S. Census Bureau's Geographic Support System (GSS) program, and commercial data. Areas not resolved in the office become the universe of geographic areas worked during In-Field Address Canvassing.

2020 Census Address Canvassing: In-Field Address Canvassing

In-Field Address Canvassing is the process of having listers visit specific geographic areas to identify every place where people could live or stay, and then to compare what they see on the ground to the existing census address list and either verify or correct the address and location information. Listers also classify each living quarter (LQ) as a housing unit or GQ. Listers will knock on doors at every structure in an attempt to locate LQs. If someone answers, the lister will provide a Confidentiality Notice and ask about the address in order to verify or update the information, as appropriate. The lister will then ask if there are any additional LQs in the structure or on the property. If there are additional LQs, the lister will collect/update that information, as appropriate. If the lister does not find anyone at home, they will update the address list as best they can by observation.

II. Method of CollectionUniverse

The 2018 End-to-End Census Test occurs in three sites within the continental United States: Pierce County, Washington, Providence County, Rhode Island, and Bluefield-Beckley-Oak Hill, West Virginia area. For the In-Field Address Canvassing data collection within the 2018 End-to-End Census Test, listers will knock on every door in their assigned blocks to ask residents about their living quarters. However, the Census Bureau expects that they would make contact with residents (i.e., someone is at home) at most 25 percent of the time.

In-Field Address Canvassing

In-Field Address Canvassing will hire new field listers, who are primarily inexperienced with census listing activities. Listers will receive work assignments grouped by geography and in close proximity to the lister's residence (whenever possible). Field staff will use the Enterprise Census and Survey Enabling (ECaSE) platform's Listing and Mapping software.

Current Design Strategy

In order to assess and accomplish the stated objectives described above, In-Office Address Canvassing clerical staff will work every block in the three sites. The In-Office Address Canvassing process will identify blocks that create the universe of blocks for In-Field Address Canvassing. The Census Bureau estimates that the 2020 Census In-Field Address Canvassing workload will be approximately 25 percent.

III. Data

OMB Control Number: 0607-XXXX.

Form Number(s): NA.

Type of Review: Regular Submission.

Affected Public: Households/Individuals.

Estimated Number of Respondents: 43,965 Households.

Estimated Time per Response: 5 min/Household.

Estimated Total Annual Burden Hours: 3,664 hours.

Estimated Total Annual Cost to Public: The only cost to respondents is that of their time to respond.

Respondent's Obligation: Mandatory.

Legal Authority: Title 13 United States Code, Sections 141 and 193.

IV. Request for Comments

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

An application has been submitted to the Foreign-Trade Zones (FTZ) Board by the Maryland Aviation Administration, on behalf of the Maryland Department of Transportation, grantee of FTZ 73, requesting subzone status for the facilities of Jos. A. Bank Manufacturing Company, located in Hampstead and Eldersburg, Maryland. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the FTZ Board (15 CFR part 400). It was formally docketed on October 13, 2016.

The proposed subzone would consist of the following sites: Site 1 (38.5 acres) 500 Hanover Pike, Hampstead; Site 2 (13.5 acres) 626 Hanover Pike, Hampstead; and, Site 3 (3.2 acres) 1332 Londontown Blvd., Eldersburg. The proposed subzone would be subject to the existing activation limit of FTZ 73. No authorization for production activity has been requested at this time.

In accordance with the FTZ Board's regulations, Kathleen Boyce of the FTZ Staff is designated examiner to review the application and make recommendations to the Executive Secretary.

Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is November 28, 2016. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to December 13, 2016.

A copy of the application will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the FTZ Board's Web site, which is accessible via www.trade.gov/ftz.

For further information, contact Kathleen Boyce at Kathleen.Boyce@trade.gov or (202) 482-1346.

Claremont Flock, a Division of Spectro Coating Corporation (Claremont Flock), submitted a notification of proposed production activity to the FTZ Board for its facility in Leominster, Massachusetts within Subzone 27N. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on October 13, 2016.

Claremont Flock already has authority to produce textile flock using acrylic and rayon tow within Subzone 27N. The current request would add polyester tow as a material/component to the scope of authority. Pursuant to 15 CFR 400.14(b), additional FTZ authority would be limited to the specific foreign-status material/component described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.

Production under FTZ procedures could exempt Claremont Flock from customs duty payments on polyester tow used in export production. On its domestic sales, Claremont Flock would be able to choose the duty rate during customs entry procedures that applies to textile flock (duty-free) for polyester tow (duty rate 7.5%). Customs duties also could possibly be deferred or reduced on foreign-status production equipment.

Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is November 28, 2016.

A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the Board's Web site, which is accessible via www.trade.gov/ftz.

For further information, contact Elizabeth Whiteman at Elizabeth.Whiteman@trade.gov or (202) 482-0473.

The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

Requests for additional information or copies of the information collection instrument and instructions should be directed to Mark Crace, BIS ICB Liaison, (202) 482-8093, Mark.Crace@bis.doc.gov.

SUPPLEMENTARY INFORMATION:I. Abstract

This collection is needed to provide a procedure for persons or organizations listed on the Entity List to request removal or modification of the entry that affects them. The Entity List appears at 15 CFR part 744, Supp. No. 1. The Entity List is used to inform the public of certain parties whose presence in a transaction that is subject to the Export Administration Regulations (15 CFR parts 730-799) requires a license from the Bureau of Industry and Security (BIS). Such requests would be reviewed by the Departments of Commerce, State, and Defense, and Energy and Treasury as appropriate. The interagency decision, as communicated to the requesting entity by BIS, would be the final agency action on such a request. This is a voluntary collection.

II. Request for Comments

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

III. Data

OMB Control Number: 0694-0134.

Title: Procedure for Parties on the Entity List to Request Removal or Modification of Their Listing.

Brief Description of Collection: This collection provides a procedure for persons or organizations listed on the Entity List to request removal or modification of the entry that affects them.

Type of Review: Extension without change of a currently approved collection.

Enforcement and Compliance, International Trade Administration, Department of Commerce.

SUMMARY:

On June 14, 2016, the Department of Commerce (the “Department”) published the preliminary results of the administrative review of the antidumping duty order on narrow woven ribbons with woven selvedge (“NWR”) from the People's Republic of China (“PRC”). The period of review (“POR”) is September 1, 2014, through August 31, 2015. The review covers one company, Yama Ribbons Co., Ltd. (“Yama Ribbons”). We invited interested parties to comment on our preliminary results. None were received. Accordingly, for the final results, we continue to find that Yama Ribbons did not have reviewable transactions during the POR.

On June 14, 2016, the Department published the Preliminary Results1 in accordance with section 751(a)(1)(B) of the Tariff Act of 1930, as amended (“the Act”). This review covers one company, Yama Ribbons Co., Ltd. (“Yama Ribbons”), for the POR of September 1, 2014, through August 31, 2015.2 The Department determined in the underlying investigation that merchandise produced and exported by Yama Ribbons is excluded from the antidumping duty order.3 However, merchandise which Yama Ribbons exports but did not produce, as well as merchandise Yama Ribbons produces but is exported by another company, remain subject to the Order. We invited interested parties to submit comments on the Preliminary Results, but no comments were received. The Department has conducted this review in accordance with section 751(a)(1)(B) of the Act.

The products covered by the order are narrow woven ribbons with woven selvedge. The merchandise subject to the order is classifiable under the Harmonized Tariff Schedule of the United States (“HTSUS”) subheadings 5806.32.1020; 5806.32.1030; 5806.32.1050 and 5806.32.1060. Subject merchandise also may enter under HTSUS subheadings 5806.31.00; 5806.32.20; 5806.39.20; 5806.39.30; 5808.90.00; 5810.91.00; 5810.99.90; 5903.90.10; 5903.90.25; 5907.00.60; and 5907.00.80 and under statistical categories 5806.32.1080; 5810.92.9080; 5903.90.3090; and 6307.90.9889. Although the HTSUS subheadings are provided for convenience and customs purposes, the written product description in the Order remains dispositive.4

4 For a complete description of the scope of the order, please see “Decision Memorandum for Preliminary Results of Antidumping Duty Administrative Review: Narrow Woven Ribbons With Woven Selvedge from the People's Republic of China,” from Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Paul Piquado, Assistant Secretary for Enforcement and Compliance (“Preliminary Decision Memorandum”), dated June 7, 2016.

Final Determination of No Shipments

As noted the in Preliminary Results, Yama Ribbons had no reviewable transactions of merchandise during the POR.5 As there are no changes from, or comments upon, the Preliminary Results, the Department finds that there is no reason to modify its analysis. Therefore, we continue to find that Yama Ribbons did not have reviewable transactions during the POR.

5See Preliminary Decision Memorandum at 5.

Assessment

The Department has determined, and U.S. Customs and Border Protection (“CBP”) shall assess, antidumping duties on all appropriate entries covered by this review, in accordance with 19 CFR 351.212(b)(1).6 The Department intends to issue assessment instructions to CBP 15 days after the date of publication of these final results of review. Pursuant to the Department's practice in non-market economy cases, because Yama Ribbons had no shipments of the subject merchandise during the POR, the Department intends to instruct CBP to liquidate entries of subject merchandise that entered under Yama Ribbons' rate at the PRC-wide rate of 247.26 percent.7

6See 19 CFR 351.212(b)(1).

7 For a full discussion of this practice, see Non-Market Economy Antidumping Proceedings: Assessment of Antidumping Duties, 76 FR 65694 (October 24, 2011).

Cash Deposit Requirements

The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of review, as provided by section 751(a)(2)(C) of the Act: (1) For exports of merchandise made by Yama Ribbons of merchandise it did not produce, the cash deposit rate is the PRC-wide rate of 247.26 percent, as stated in the Order;8 (2) for previously investigated or reviewed PRC and non-PRC exporters which are not under review in this segment of the proceeding but which have been determined by Commerce to have a separate rate, the cash deposit rate will continue to be the exporter-specific rate published for the most recent period; (3) for all PRC exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be the PRC-wide rate of 247.26 percent; and (4) for all non-PRC exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the PRC exporter(s) that supplied that non-PRC exporter. These deposit requirements, when imposed, shall remain in effect until further notice.

8See Order.

Notification to Importers Regarding the Reimbursement of Duties

This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties has occurred and the subsequent assessment of doubled antidumping duties.

Notification to Interested Parties

This notice also serves as a reminder to parties subject to the administrative protective order (“APO”) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely notification of the destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.

We are issuing and publishing these results and this notice in accordance with sections 751(a)(1) and 777(i) of the Act.

National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:

Notice; public meeting.

SUMMARY:

The New England Fishery Management Council (Council) is scheduling a public meeting of its Enforcement Committee and Advisory Panel to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.

DATES:

This meeting will be held on Thursday, November 3, 2016, beginning at 9:30 a.m.

ADDRESSES:

The meeting will be held at the Sheraton Providence Airport, 1850 Post Road, Warwick, RI 02886; phone: (401) 738-4000.

The Enforcement Committee will meet jointly with its Advisory Panel to discuss Cod-end certification. Also on the agenda is the review of Atlantic herring closure proposals (inshore and haddock protection). They will receive a presentation by the Anthropocene Institute. The Committee only will then meet in closed session to select new advisors. Other business will be discussed as needed.

Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.

Special Accommodations

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.

National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:

Notice; public meeting.

SUMMARY:

The Pacific Fishery Management Council's (Pacific Council) Ad Hoc Community Advisory Board (CAB) will hold a two-day meeting that is open to the public.

DATES:

The CAB meeting will begin Wednesday, November 2, 2016 at 8 a.m. and recess when business for the day is completed. It will continue at 8 a.m. Thursday, November 3, 2016, adjourning when business for the day is completed.

The primary purpose of the CAB meeting is to develop recommendations for the Pacific Council pertaining to plans for its five-year review of the groundfish trawl catch share program (implemented pursuant to Amendment 20 of its groundfish fishery management plan). The CAB's immediate task is to comment on the detailed outline (blueprint) for the review document. The CAB may also begin some initial work on the identification of issues that may be taken up as follow-on regulatory actions pursuant to the results of the review. Additionally, the CAB will receive a presentation from the Northwest Fisheries Science Center, Economic Data Collection Program on data collected from catch share program participants. The CAB's recommendations on the review will be conveyed for consideration by the Pacific Council at its November meeting in Garden Grove, California. During the November meeting, the Council will provide guidance to analysts that will be drafting the review.

Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during the meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.

Special Accommodations

The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt at (503) 820-2425 at least 10 business days prior to the meeting date.

The Commodity Futures Trading Commission (Commission) is publishing this notice to announce the renewal of the Technology Advisory Committee (TAC). The Commission has determined that the renewal of the TAC is necessary and in the public's interest, and the Commission has consulted with the General Services Administration's Committee Management Secretariat regarding the TAC's renewal.

The TAC's objectives and scope of activities shall be to conduct public meetings, to submit reports and recommendations to the Commission, and to otherwise assist the Commission in identifying and understanding the impact and implications of technological innovation in the financial services and commodity markets. The TAC will provide advice on the application and utilization of new technologies in financial services and commodity markets, as well as by market professionals and market users. The TAC will provide advice to the Commission on the appropriate level of investment in technology at the Commission to meet its surveillance and enforcement responsibilities, and advise the Commission on the need for strategies to implement rules and regulations to support the Commission's mission of ensuring the integrity of the markets.

The TAC will operate for two years from the date of renewal unless the Commission directs that the TAC terminate on an earlier date. A copy of the TAC renewal charter has been filed with the Commission; the Senate Committee on Agriculture, Nutrition and Forestry; the House Committee on Agriculture; the Library of Congress; and the General Services Administration's Committee Management Secretariat. A copy of the renewal charter will be posted on the Commission's Web site at www.cftc.gov.

The Office of Federal Sustainability Council on Environmental Quality (CEQ) has issued to Federal agency Chief Sustainability Officers Guidance for Federal Agency Implementation of Workplace Charging Pursuant to the Fixing America's Surface Transportation (FAST) Act: Electric Vehicle Supply Equipment. The guidance outlines how Federal agencies can take advantage of workplace charging opportunities under the FAST Act, and provides an approach for a uniform fee for the use of existing and new hard-wired electric vehicle supply equipment (EVSE) with cordsets including alternating current (AC) Level 1 EVSE, AC Level 2 EVSE, or direct current fast chargers (DCFC), for the purposes of seeking reimbursement under the FAST Act. The document also describes how Federal agency Chief Sustainability Officers should coordinate with Federal agency fleet managers to report annually on the implementation of workplace charging in the Federal Automotive Statistical Tool (FAST).

This guidance document applies only to Federal agency buildings not under the jurisdiction, custody, or control of the General Services Administration. Agencies are expected to follow the Guidance for Federal Agency Implementation of Workplace Charging Pursuant to the Fixing America's Surface Transportation (FAST) Act: Electric Vehicle Supply Equipment as part of their compliance with E.O. 13693.

On October 5, 2016 (81 FR 69052-69053), the Department of Defense published a notice announcing a meeting of the Defense Business Board. The Department of Defense announces that the meeting location has changed. All other information in the October 5, 2016 notice remains the same.

DATES:

The public meeting of the Defense Business Board (“the Board”) will be held on Thursday, October 20, 2016. The meeting will begin at 10:15 a.m. and end at 11:45 a.m. (Escort required; see guidance in the SUPPLEMENTARY INFORMATION section, “Public's Accessibility to the Meeting.”)

ADDRESSES:

The meeting will now be held in Room 3E928 in the Pentagon, Washington, DC (Escort required; See guidance in the SUPPLEMENTARY INFORMATION section, “Public's Accessibility to the Meeting.”)

Due to difficulties beyond the control of the Department of Defense, the Designated Federal Officer was unable to submit the Federal Register notice pertaining to the meeting address change to the Defense Business Board scheduled meeting for October 20, 2016, that ensured compliance with the requirements of 41 CFR 102-3.150(a). Accordingly, the Advisory Committee Management Officer for the Department of Defense waives the 15-calendar day notification requirement pursuant to 41 CFR 102-3.150(b).

This meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.140.

Under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150, the Department of Defense announces that the meeting location has changed.

Public's Accessibility to the Meeting: Pursuant to FACA and 41 CFR 102-3.140, this meeting is open to the public. Seating is limited and is on a first-come basis. All members of the public who wish to attend the public meeting must contact Steven Cruddas at the number listed in the FOR FURTHER INFORMATION CONTACT section to register and make arrangements for a Pentagon escort, if necessary. Public attendees requiring escort should arrive at the Pentagon Visitor's Center, located near the Pentagon Metro Station's south exit (the escalators to the left upon exiting through the turnstiles) and adjacent to the Pentagon Transit Center bus terminal, with sufficient time to complete security screening and be admitted to the Pentagon no later than 10:00 a.m. on October 20. Note: Pentagon tour groups enter through the Visitor's Center, so long lines could form well in advance. To complete security screening, please come prepared to present two forms of identification of which one must be a pictured identification card. Government and military DoD CAC holders without Pentagon access are not required to have an escort; however, they are still required to pass through the Visitor's Center to gain access to the Building.

Special Accommodations: Individuals requiring special accommodations to access the public meeting should contact Steven Cruddas so that appropriate arrangements can be made.

The Department of Energy (DOE), pursuant to the Paperwork Reduction Act of 1995, intends to extend for three years, an information collection request with the Office of Management and Budget (OMB). Comments are invited on: (a) Whether the extended collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

DATES:

Comments regarding this proposed information collection must be received on or before December 19, 2016. If you anticipate difficulty in submitting comments within that period, contact the person listed below as soon as possible.

ADDRESSES:

Written comments may be sent to Richard Goorevich, Senior Policy Advisor, Office of Nonproliferation and Arms Control, National Nuclear Security Administration, U.S. Department of Energy, 1000 Independence Ave. SW., Washington, DC 20585, or by fax at 202-586-1348 or by email at richard.goorevich@nnsa.doe.gov.

FOR FURTHER INFORMATION CONTACT:

Richard Goorevich, Senior Policy Advisor, Office of Nonproliferation and Arms Control, National Nuclear Security Administration, U.S. Department of Energy, 1000 Independence Ave. SW., Washington, DC 20585, or by fax at 202-586-1348 or by email at richard.goorevich@nnsa.doe.gov.

SUPPLEMENTARY INFORMATION:

This information collection request contains: (1) OMB No.1910-5173; (2) Information Collection Request Title: The American Assured Fuel Supply Program; (3) Type of Review: Extension; (4) Purpose: The U.S. Department of Energy (DOE) created the American Assured Fuel Supply (AFS), a reserve of low enriched uranium (LEU) to serve as a backup fuel supply for foreign recipients to be supplied through U.S. persons or for domestic recipients, in the event of fuel supply disruption. DOE is committed to making the AFS available to eligible recipients in the case of supply disruptions in the nuclear fuel market. This effort supports the United States Government's nuclear nonproliferation objectives by supporting civilian nuclear energy development while minimizing proliferation risks. DOE published a Notice of Availability for AFS on August 18, 2011, and published an application on December 2, 2013, in the Federal Register to standardize the information that must be provided in a request to access the material in the AFS as set forth in the Notice of Availability 76 FR 51357, 51358. This application form is necessary in order for DOE to identify if applicants meet basic requirements for use of the AFS and implement this important nonproliferation initiative; (5) Annual Estimated Number of Respondents: 10; (6) Annual Estimated Number of Total Responses: 10; (7) Annual Estimated Number of Burden Hours: 8; (8) Annual Estimated Reporting and Recordkeeping Cost Burden: $1,800.

Statutory Authority: The Secretary of Energy is authorized pursuant to the Atomic Energy Act of 1954, as amended (Pub. L. 83-703), and the Nuclear Non-Proliferation Act of 1978 (NNPA) (Pub. L. 95-242) to encourage the widespread use of atomic energy for peaceful purposes, and to cooperate with other nations by distributing nuclear material where appropriate safeguards measures are in place to ensure the material is properly controlled and used for peaceful purposes. In 2005, DOE set aside a portion of its LEU inventory to be used to support the International Atomic Energy Agency's (IAEA) International Nuclear Fuel Bank (INFB) initiative, which is envisioned as an LEU reserve that will be administered by the IAEA and that will serve as a back-up for global supply disruptions. Congress later appropriated $49,540,000 in the Consolidated Appropriations Act, 2008 (Pub. L. 110-161) to fund a portion of the INFB. Congress, in the Explanatory Statement accompanying the House Appropriations Committee Print (which in the Act was given the same effect as a joint explanatory statement), noted that the INFB freed up DOE's LEU set-aside, and recommended DOE also “allow U.S. interests to purchase uranium fuel from the Reliable Fuel Supply [now the AFS] in the event of supply disruption.” (H. Approp. Cmte. Print at 592.)

The sale of LEU from the AFS will be conducted consistent with applicable law, the policies and guidance in the “Secretary of Energy's 2008 Policy Statement of Management of the Department of Energy's Excess Uranium Inventory” (March 11, 2008), and the DOE Excess Uranium Inventory Management Plan.

On October 12, 2016, the Commission issued an order in Docket No. EL16-114-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into the justness and reasonableness of the Idaho Power Company's market-based rate authority in the Idaho Power balancing authority area. Idaho Power Company, 157 FERC ¶ 61,017 (2016).

The refund effective date in Docket No. EL16-114-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the Federal Register.

Any interested person desiring to be heard in Docket No. EL16-114-000 must file a notice of intervention or motion to intervene, as appropriate, with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rule 214 of the Commission's Rules of Practice and Procedure, 18 CFR 385.214 (2016), within 30 days of the date of issuance of the order.

The staff of the Federal Energy Regulatory Commission (FERC or Commission) will prepare an environmental assessment (EA) that will discuss the environmental impacts of the Lone Star Project involving construction and operation of facilities by Tennessee Gas Pipeline Company, L.L.C. (Tennessee) in San Patricio and Jackson Counties, Texas. The Commission will use this EA in its decision-making process to determine whether the project is in the public convenience and necessity.

This notice announces the opening of the scoping process the Commission will use to gather input from the public and interested agencies on the project. You can make a difference by providing us with your specific comments or concerns about the project. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. Your input will help the Commission staff determine what issues they need to evaluate in the EA. To ensure that your comments are timely and properly recorded, please send your comments so that the Commission receives them in Washington, DC on or before November 14, 2016.

If you sent comments on this project to the Commission before the opening of this docket on September 1, 2016, you will need to file those comments in Docket No. CP16-496-000 to ensure they are considered as part of this proceeding.

This notice is being sent to the Commission's current environmental mailing list for this project. State and local government representatives should notify their constituents of this proposed project and encourage them to comment on their areas of concern.

If you are a landowner receiving this notice, a pipeline company representative may contact you about the acquisition of an easement to construct, operate, and maintain the proposed facilities. The company would seek to negotiate a mutually acceptable agreement. However, if the Commission approves the project, that approval conveys with it the right of eminent domain. Therefore, if easement negotiations fail to produce an agreement, the pipeline company could initiate condemnation proceedings where compensation would be determined in accordance with state law.

Tennessee provided landowners with a fact sheet prepared by the FERC entitled “An Interstate Natural Gas Facility On My Land? What Do I Need To Know?” This fact sheet addresses a number of typically asked questions, including the use of eminent domain and how to participate in the Commission's proceedings. It is also available for viewing on the FERC Web site (www.ferc.gov).

Public Participation

For your convenience, there are three methods you can use to submit your comments to the Commission. The Commission encourages electronic filing of comments and has expert staff available to assist you at (202) 502-8258 or efiling@ferc.gov. Please carefully follow these instructions so that your comments are properly recorded.

(1) You can file your comments electronically using the eComment feature on the Commission's Web site (www.ferc.gov) under the link to Documents and Filings. This is an easy method for submitting brief, text-only comments on a project;

(2) You can file your comments electronically by using the eFiling feature on the Commission's Web site (www.ferc.gov) under the link to Documents and Filings. With eFiling, you can provide comments in a variety of formats by attaching them as a file with your submission. New eFiling users must first create an account by clicking on “eRegister.” If you are filing a comment on a particular project, please select “Comment on a Filing” as the filing type; or

(3) You can file a paper copy of your comments by mailing them to the following address. Be sure to reference the project docket number (CP16-496-000) with your submission: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC 20426.

Summary of the Proposed Project

Tennessee proposes to construct and operate the following facilities as part of the Lone Star Project: (1) A new 10,915 horsepower compressor station (CS 3A) in San Patricio County, Texas; and (2) a new 10,500 horsepower compressor station (CS 11A) in Jackson County, Texas. The proposed facilities would be on Tennessee's existing Line 100 and would allow Tennessee to provide firm incremental transportation service of up to 300,000,000 cubic feet per day to the Corpus Christi Liquefaction, LLC facility currently under construction in San Patricio County, Texas.

The general location of the project facilities is shown in appendix 1.1

1 The appendices referenced in this notice will not appear in the Federal Register. Copies of appendices were sent to all those receiving this notice in the mail and are available at www.ferc.gov using the link called “eLibrary” or from the Commission's Public Reference Room, 888 First Street NE., Washington, DC 20426, or call (202) 502-8371. For instructions on connecting to eLibrary, refer to the last page of this notice.

Land Requirements for Construction

Construction of the two compressor stations would disturb about 113 acres of land, of which 27 acres Tennessee would maintain for permanent operation of the Project. Construction of CS 3A would disturb about 72.2 acres of land, of which Tennessee would permanently maintain 13.4 acres during operation of the facility. The fenced compressor station site for CS 3A would account for about 12.5 acres, including the access road. Construction of CS 11A would disturb about 41.1 acres of land, of which Tennessee would permanently maintain 14.0 acres during operation of the facility, including the access road. The fenced compressor station site for CS 11A would account for approximately 12.2 acres.

The EA Process

The National Environmental Policy Act (NEPA) requires the Commission to take into account the environmental impacts that could result from an action whenever it considers the issuance of a Certificate of Public Convenience and Necessity. NEPA also requires us 2 to discover and address concerns the public may have about proposals. This process is referred to as “scoping.” The main goal of the scoping process is to focus the analysis in the EA on the important environmental issues. By this notice, the Commission requests public comments on the scope of the issues to address in the EA. We will consider all filed comments during the preparation of the EA.

2 “We,” “us,” and “our” refer to the environmental staff of the Commission's Office of Energy Projects.

In the EA we will discuss impacts that could occur as a result of the construction and operation of the proposed project under these general headings:

• geology and soils;• land use;• water resources, fisheries, and wetlands;• cultural resources;• vegetation and wildlife;• air quality and noise;• endangered and threatened species;• socioeconomics;• public safety; and• cumulative impacts

We will also evaluate reasonable alternatives to the proposed project or portions of the project, and make recommendations on how to lessen or avoid impacts on the various resource areas.

The EA will present our independent analysis of the issues. The EA will be available in the public record through eLibrary. Depending on the comments received during the scoping process, we may also publish and distribute the EA to the public for an allotted comment period. We will consider all comments on the EA before making our recommendations to the Commission. To ensure we have the opportunity to consider and address your comments, please carefully follow the instructions in the Public Participation section, beginning on page 2.

With this notice, we are asking agencies with jurisdiction by law and/or special expertise with respect to the environmental issues of this project to formally cooperate with us in the preparation of the EA.3 Agencies that would like to request cooperating agency status should follow the instructions for filing comments provided under the Public Participation section of this notice.

3 The Council on Environmental Quality regulations addressing cooperating agency responsibilities are at Title 40, Code of Federal Regulations, Part 1501.6.

Consultations Under Section 106 of the National Historic Preservation Act

In accordance with the Advisory Council on Historic Preservation's implementing regulations for section 106 of the National Historic Preservation Act, we are using this notice to initiate consultation with the applicable State Historic Preservation Office (SHPO), and to solicit their views and those of other government agencies, interested Indian tribes, and the public on the project's potential effects on historic properties.4 We will define the project-specific Area of Potential Effects (APE) in consultation with the SHPO as the project develops. On natural gas facility projects, the APE at a minimum encompasses all areas subject to ground disturbance (examples include contractor/pipe storage yards, compressor stations, and access roads). Our EA for this project will document our findings on the impacts on historic properties and summarize the status of consultations under section 106.

4 The Advisory Council on Historic Preservation's regulations are at Title 36, Code of Federal Regulations, Part 800. Those regulations define historic properties as any prehistoric or historic district, site, building, structure, or object included in or eligible for inclusion in the National Register of Historic Places.

Environmental Mailing List

The environmental mailing list includes federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American Tribes; other interested parties; and local libraries and newspapers. This list also includes all affected landowners (as defined in the Commission's regulations) who are potential right-of-way grantors, whose property may be used temporarily for project purposes, or who own homes within certain distances of aboveground facilities, and anyone who submits comments on the project. We will update the environmental mailing list as the analysis proceeds to ensure that we send the information related to this environmental review to all individuals, organizations, and government entities interested in and/or potentially affected by the proposed project. If we publish and distribute the EA, copies will be sent to the environmental mailing list for public review and comment. If you would prefer to receive a paper copy of the document instead of the CD version or would like to remove your name from the mailing list, please return the attached Information Request (appendix 2).

Becoming an Intervenor

In addition to involvement in the EA scoping process, you may want to become an “intervenor” which is an official party to the Commission's proceeding. Intervenors play a more formal role in the process and are able to file briefs, appear at hearings, and be heard by the courts if they choose to appeal the Commission's final ruling. An intervenor formally participates in the proceeding by filing a request to intervene. Instructions for becoming an intervenor are in the “Document-less Intervention Guide” under the “e-filing” link on the Commission's Web site. Motions to intervene are more fully described at http://www.ferc.gov/resources/guides/how-to/intervene.asp.

Additional Information

Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC Web site at www.ferc.gov using the “eLibrary” link. Click on the eLibrary link, click on “General Search” and enter the docket number, excluding the last three digits in the Docket Number field (i.e., CP16-496). Be sure you have selected an appropriate date range. For assistance, please contact FERC Online Support at FercOnlineSupport@ferc.gov or toll free at (866) 208-3676, or for TTY, contact (202) 502-8659. The eLibrary link also provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rulemakings.

In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

Finally, public meetings or site visits will be posted on the Commission's calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along with other related information.

Take notice that the Commission received the following electric corporate filings:

Docket Numbers: EC16-164-000.

Applicants: Georgia Power Company.

Description: Amendment to August 8, 2016 Application of Georgia Power Company Pursuant to Section 203 of the Federal Power Act for Authorization to Sell Certain Transmission Facilities and Request for Expedited Action.

Filed Date: 10/12/16.

Accession Number: 20161012-5171.

Comments Due: 5 p.m. ET 11/2/16.

Docket Numbers: EC17-1-000.

Applicants: Entergy Mississippi, Inc.

Description: Supplement to October 3, 2016 Application of Entergy Mississippi, Inc. under Section 203 [Exhibits A through L and replacement Exhibit M].

Filed Date: 10/12/16.

Accession Number: 20161012-5184.

Comments Due: 5 p.m. ET 11/2/16.

Take notice that the Commission received the following electric rate filings:

The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

Take notice that on October 7, 2016, pursuant to section 292.205(c) of the Federal Energy Regulatory Commission's (Commission) Rules and Regulations, implementing the Public Utility Regulatory Policies Act of 1978, Gregory Power Partners LLC filed a petition for limited waiver of the Commission qualifying cogeneration facility operating and efficiency standards set forth in 18 CFR 292.205(a)(1)(2), for the rest of calendar year 2016 and 2017, all as more fully explained in the petition.

Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Petitioner.

The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

This filing is accessible on-line at http://www.ferc.gov, using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email FERCOnlineSupport@ferc.gov, or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

Take notice that on October 4, 2016, Oncor Electric Delivery Company LLC submitted its tariff filing: Oncor Electric Delivery Company LLC TFO Rate Changes to be effective September 15, 2016.

Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant and all the parties in this proceeding.

The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

This filing is accessible on-line at http://www.ferc.gov, using the “eLibrary” link and is available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email FERCOnlineSupport@ferc.gov, or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

Take notice that on October 4, 2016, Oncor Electric Delivery Company LLC submitted its tariff filing: Tex-La Electric Cooperative of Texas Tariff Rate Changes to be effective September 15, 2016.

Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant and all the parties in this proceeding.

The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

This filing is accessible online at http://www.ferc.gov, using the “eLibrary” link and is available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email FERCOnlineSupport@ferc.gov, or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

Notice of amendments to an existing system of records; two new routine use(s).

SUMMARY:

The Federal Communications Commission (FCC or Commission) is amending an existing system of records, FCC/MB-1, Ownership Reports for Commercial and Noncommercial Broadcast Stations (previously FCC/MB-1, Ownership Report for Commercial Broadcast Stations), subject to the Privacy Act of 1974, as amended. This action is necessary to meet the requirements of the Privacy Act to publish in the Federal Register notice of the existence and character of records maintained by the agency. The FCC's Media Bureau (MB) will use the information contained in this altered system of records to administer the Commission's regulatory responsibilities that relate to ownership of commercial broadcast stations, including AM and FM radio and television (full power, Class A, and low power); ownership of noncommercial broadcast stations, including AM and FM radio and full-power television; and ownership of interests in daily newspapers that are subject to the Commission's media ownership rules.

DATES:

Written comments are due on or before November 18, 2016. This action will become effective on November 28, 2016 unless comments are received that require a contrary determination.

Leslie F. Smith, (202) 418-0217, or Leslie.Smith@fcc.gov, and to obtain a copy of the Narrative Statement, which includes details of the proposed alterations to this system of records.

SUPPLEMENTARY INFORMATION:

The FCC previously gave notice of this system of records, FCC/MB-1, Ownership Reports for Commercial and Noncommercial Broadcast Stations (previously FCC/MB-1, Ownership Report for Commercial Broadcast Stations), by publication in the Federal Register on November 19, 2009 (74 FR 59978). This notice serves to update and amend FCC/MB-1 as a result of revised requirements that the FCC adopted for reporting certain ownership and/or attributable interests in broadcast stations.

(3) Individuals with ownership or attributable interests in media companies subject to the Commission's ownership rules or otherwise required to be reported on Form 2100, Schedule 323 (formerly Form 323), and/or Form 2100, Schedule 323-E (formerly Form 323-E); and

(4) Individuals who are married to or related (i.e., parent-child or siblings, etc.) to other individuals who have attributable, reportable, and/or ownership interests and who must either file Form 2100, Schedule 323 (formerly Form 323), or have their interests reported on Form 2100, Schedule 323 (formerly Form 323).

CATEGORIES OF RECORDS IN THE SYSTEM:

The categories of records in this system include but are not limited to:

(2) All exhibits, organizational charts, correspondence, i.e., letters, etc., supporting documentation, and other materials, etc., which are associated with processing Form 2100, Schedule 323 (formerly Form 323), and Form 2100, Schedule 323-E (formerly Form 323-E) submissions; and

(3) Any other records that are submitted in connection with or created as the result of the filing of Form 2100, Schedule 323 (formerly Form 323), and/or Form 2100, Schedule 323-E (formerly Form 323-E).

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

47 CFR 73.3555, 73.3615, 73.6026, and 74.797.

PURPOSES:

The information obtained from Form 2100, Schedule 323 (formerly Form 323), and Form 2100, Schedule 323-E (formerly Form 323-E) submissions is kept to administer the Commission's regulatory responsibilities that relate to the ownership of commercial broadcast stations, including AM and FM radio and television (full power, Class A, and low power); ownership of noncommercial broadcast stations, including AM and FM radio and full-power television; and ownership of interests in daily newspapers that are subject to the Commission's media ownership rules. The Commission uses these records in this system:

(1) To assess the data contained in responses to Form 2100, Schedule 323 (formerly Form 323), and/or Form 2100, Schedule 323-E (formerly Form 323-E), which the Commission uses to evaluate licensees' or permittees' compliance with the Commission's media ownership rules, etc., and other related uses. These forms are filed:

(b) As a validation and resubmission of a previously filed Biennial Ownership Report;

(c) In connection with the transfer of control or assignment of a broadcast station;

(d) By a permittee within 30 days after the grant of a construction permit and on the date that the permittee files its license application;

(e) As a certification of accuracy of the initial or post-consummation Ownership Report filed by the permittee in conjunction with its application for a station license; or

(f) As an amendment of a previously filed Ownership Report.

(2) To undertake studies of minority and female ownership that include but are not limited to: Studies that support the Commission's diversity policy goals and other ownership studies to support its statutory requirement to review the media ownership goals quadrennially to determine whether they are necessary in the public interest as the result of competition.

(3) Any other uses of Form 2100, Schedule 323 (formerly Form 323), and/or Form 2100, Schedule 323-E (formerly Form 323-E), within the Commission's authority.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES:

In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed to authorized entities, as is determined to be relevant and necessary, outside the FCC as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows. In each of these cases, the FCC will determine whether disclosure of the records is compatible with the purpose(s) for which the records were collected.

1. Public Access—Under the rules of the Commission, documents filed in MB's Consolidated Database System (CDBS) are publicly available. Form 2100, Schedule 323, and Form 2100, Schedule 323-E—the revised versions of Forms 323 and 323-E, respectively—will be implemented in MB's Licensing and Management System (LMS). Documents filed in LMS are publicly available via the Commission's Web site;

2. Adjudication and Litigation—To the Department of Justice (DOJ), or other administrative body before which the FCC is authorized to appear, when: (a) The FCC or any component thereof; or (b) any employee of the FCC in his or her official capacity; or (c) any employee of the FCC in his or her individual capacity where DOJ or the FCC has agreed to represent the employee; or (d) the United States is a party to litigation or has an interest in such litigation, and the use of such records by the DOJ or the FCC is deemed by the FCC to be relevant and necessary to the litigation;

3. Financial Obligations under the Debt Collection Acts—To other Federal agencies for the purpose of collecting and reporting on delinquent debts as authorized by the Debt Collection Act of 1982 or the Debt Collection Improvement Act of 1996. A record from this system may be disclosed to any Federal, state, or local agency to conduct an authorized computer matching program in compliance with the Privacy Act of 1974, as amended, to identify and locate individuals who are delinquent in their repayment of certain debts owed to the U.S. Government. A record from this system may be used to prepare information on items considered income for taxation purposes to be disclosed to Federal, state, and local governments;

4. Law Enforcement and Investigation—To disclose pertinent information to the appropriate Federal, State, or local agency responsible for investigating, prosecuting, enforcing, or implementing a statute, rule, regulation, or order, where the FCC becomes aware of an indication of a violation or potential violation of a civil or criminal law or regulation;

5. Congressional Inquiries—To provide information to a congressional office from the record of an individual in response to an inquiry made from that congressional office made at the request of that individual;

6. Government-wide Program Management and Oversight—To the National Archives and Records Administration (NARA) for use in its records management inspections; to the Government Accountability Office (GAO) for oversight purposes; to DOJ in order to obtain that department's advice regarding disclosure obligations under the Freedom of Information Act (FOIA); or to the Office of Management and Budget (OMB) in order to obtain that office's advice regarding obligations under the Privacy Act;

7. Breach Notification—To appropriate agencies, entities, and persons when (a) the Commission suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the Commission has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the Commission or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Commission's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm; and

8. Non-Federal Personnel—To disclose information to contractors performing or working on a contract for the Federal Government.

DISCLOSURE TO CONSUMER REPORTING AGENCIES:

None.

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM:STORAGE:

The Broadcast Station Ownership database is the repository for all electronically filed ownership reports and associated information, including exhibits (e.g., organizational charts, appendices, scanned images, and all other supplementary documents and materials, etc.). All Form 323 and Form 323-E filings must be submitted electronically (e.g., paper copy filings are not acceptable). Form 323 and Form 323-E filings are currently submitted via CDBS, at https://www.fcc.gov/media/filing-systems-and-databases. Filings on Form 2100, Schedule 323, and Form 2100, Schedule 323-E—the revised versions of Forms 323 and 323-E, respectively—will be submitted electronically via LMS, at https://enterpriseefiling.fcc.gov/dataentry/login.html.

RETRIEVABILITY:

Information in this system is publicly retrievable. The information may be viewed via the “Public Access” Search functionality in CDBS, at https://www.fcc.gov/media/filing-systems-and-databases, by clicking on the “Ownership Search” link. Information may be retrieved by searching electronically using a variety of parameters including the call sign, facility ID number, service, file number, application type, channel, frequency, community of license city and state, name of the licensee/permittee, or name/address of the person or entity holding the interest reported on Form 323 or Form 323-E. All ownership data can also be downloaded via a set of files that correspond to database tables from the Media Bureau Public CDBS Database Files Web site: https://www.fcc.gov/media/radio/cdbs-database-public-files. Information is retrieved internally via database commands by authorized FCC staff and contractors who have been granted permission to access the data. Form 2100, Schedule 323, and Form 2100, Schedule 323-E—the revised versions of Forms 323 and 323-E, respectively—will be implemented in LMS. Information filed in LMS may be viewed via the “LMS Public Search” functionality in LMS, at https://enterpriseefiling.fcc.gov/dataentry/login.html. LMS Public Database Tables may be downloaded from the LMS Public Database Files Web site: https://enterpriseefiling.fcc.gov/dataentry/public/tv/lmsDatabase.html.

SAFEGUARDS:

Information in these records and files is available to the public via the FCC Internet portal at: https://www.fcc.gov/media/filing-systems-and-databases. Access to the ownership records housed in the CDBS and LMS databases is restricted to authorized MB supervisory and staff and IT staff and contractors, who maintain the CDBS and LMS network computer databases. Other FCC staff and contractors may be granted access to this information, only on a “need-to-know” basis.

The CDBS and LMS databases are part of the FCC's computer network databases. The FCC's computer network is protected by a comprehensive and dynamic set of IT safety and security protocols and features that are designed to meet all Federal IT privacy standards, including those required by the National Institute of Standards and Technology (NIST) and the Federal Information Security Management Act (FISMA).

RETENTION AND DISPOSAL:

The information in this system is limited to electronic files, records, and data, which includes:

(1) The information that pertains to current filing requirements; and

(2) the information that pertains to historical records, which is used for archival purposes. The agency records control schedule N1-173-86-2, approved by NARA, authorizes permanent retention of original documents of information reported pursuant to Sections 73.3613 and 73.3615 of the Commission's rules, including ownership reports (FCC Form 323). Until NARA approves an appropriate records schedule, any information in this system that is not covered by the agency records control schedule N1-173-86-2 will also be treated as permanent.

Individuals wishing to determine whether this system of records contains information about them may do so by writing to Leslie F. Smith, Privacy Manager, Information Technology (IT), Federal Communications Commission (FCC), 445 12th Street SW., Washington, DC 20554 or Leslie.Smith@fcc.gov.

Individuals must furnish reasonable identification by showing any two of the following: Social security card; driver's license; employee identification card; Medicare card; birth certificate; bank credit card; or other positive means of identification, or by signing an identity statement stipulating that knowingly or willfully seeking or obtaining access to records about another person under false pretenses is punishable by a fine of up to $5,000.

Individuals requesting access must also comply with the FCC's Privacy Act regulations regarding verification of identity and access to records (5 CFR part 0, subpart E).

RECORD ACCESS PROCEDURES:

Access to Form 323 and Form 323-E submissions is available through the Commission's Web site as stated above, at https://www.fcc.gov/media/filing-systems-and-databases. Form 2100, Schedule 323, and Form 2100, Schedule 323-E—the revised versions of Forms 323 and 323-E, respectively—will be implemented in LMS, and documents filed in LMS are publicly available through the Commission's Web site. Individuals wishing to obtain additional information about records in this system should follow the Notification Procedure above.

CONTESTING RECORD PROCEDURES:

Individuals wishing to contest information pertaining to them in the system of records should follow the Notification Procedure above.

RECORD SOURCE CATEGORIES:

The sources for the information in this system are all entities that are required to file an ownership report, either biennially or at other occasions, under 47 CFR 73.3615, 73.6026, and 74.797 of the Commission's rules, and include but are not limited to:

(1) Licensees, permittees, and respondents, and other individuals or entities with interests therein that are required to file or have their interests reported on:

(3) Individuals with ownership or attributable interests in media companies subject to the Commission's ownership rules or otherwise required to be reported on Form 2100, Schedule 323 (formerly Form 323), and/or Form 2100, Schedule 323-E (formerly Form 323-E); and

(4) Individuals who are married to or related (i.e., parent-child or siblings, etc.) to other individuals who have attributable, reportable, and/or ownership interests and who must either file Form 2100, Schedule 323 (formerly Form 323), or have their interests reported on Form 2100, Schedule 323 (formerly Form 323).

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

DATES:

Written PRA comments should be submitted on or before December 19, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

ADDRESSES:

Direct all PRA comments to Nicole Ongele, FCC, via email to PRA@fcc.gov and to Nicole.Ongele@fcc.gov.

FOR FURTHER INFORMATION CONTACT:

For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.

OMB Control Number: 3060-0809.

Title: Communications Assistance for Law Enforcement Act (CALEA).

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for profit entities.

Number of Respondents and Responses: 200 respondents; 285 responses.

Estimated Time per Response: 12 hours average (range of 7.5 to 80 hours).

Frequency of Response: On occasion reporting requirements, recordkeeping and third party disclosure requirements.

Obligation to Respond: Mandatory and Voluntary. Statutory authority is contained in sections 105, 107(c), 109(b) and 301 of the Communications Assistance for Law Enforcement Act (CALEA), 47 U.S.C. 1004, 1006(c), 1008(b), and 229; Public Law 103-414, 108 Stat. 4279 (1994).

Total Annual Burden: 3,475 hours.

Total Annual Cost: No Cost.

Privacy Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: CALEA records submitted pursuant to this information collection are not made available routinely for public inspection.

Needs and Uses: The Communications Assistance for Law Enforcement Act (CALEA) requires the Commission to create rules that regulate the conduct and recordkeeping of lawful electronic surveillance. CALEA was enacted in October 1994 to respond to rapid advances in telecommunications technology and eliminates obstacles faced by law enforcement personnel in conducting electronic surveillance. Section 105 of CALEA requires telecommunications carriers to protect against the unlawful interception of communications passing through their systems. Law enforcement officials use the information maintained by telecommunications carriers to determine the accountability and accuracy of telecommunications carriers' compliance with lawful electronic surveillance orders.

On May 12, 2006, the Commission released a Second Report and Order and Memorandum Opinion and Order in ET Docket No. 04-195, FCC 06-56, which became effective August 4, 2006, except for §§ 1.20004 and 1.2005 of the Commission's rules, which became effective on February 12, 2007. The Second Report and Order established new guidelines for filing section 107(c) petitions, section 109(b) petitions, and monitoring reports (FCC Form 445). CALEA section 107(c)(1) permits a petitioner to apply for an extension of time, up to two years from the date that the petition is filed, and to come into compliance with a particular CALEA section 103 capability requirement. CALEA section 109(b) permits a telecommunication carrier covered by CALEA to file a petition with the FCC and an application with the Department of Justice (DOJ) to request that DOJ pay the costs of the carrier's CALEA compliance (cost-shifting relief) with respect to any equipment, facility or service installed or deployed after January 1, 1995. The Second Report and Order required several different collections of information:

(a) Within 90 days of the effective date of the Second Report and Order, facilities based broadband Internet access and interconnected Voice over Interconnected Protocol (VOIP) providers newly identified in the First Report and Order in this proceeding were required to file system security statements under the Commission's rules. (Security systems are currently approved under the existing OMB Control No. 3060-0809 information collection).

(b) All telecommunications carriers, including broadband Internet access and interconnected VoIP providers, must file updates to their systems security statements on file with the Commission as their information changes.

(c) Petitions filed under Section 107(c), request for additional time to comply with CALEA; these provisions apply to all carriers subject to CALEA and are voluntary filings.

(d) Section 109(b), request for reimbursement of CALEA; these provisions apply to all carriers subject to CALEA and are voluntary filings.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

DATES:

Written PRA comments should be submitted on or before December 19, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

ADDRESSES:

Direct all PRA comments to Nicole Ongele, FCC, via email to PRA@fcc.gov and to Nicole.Ongele@fcc.gov.

FOR FURTHER INFORMATION CONTACT:

For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.

SUPPLEMENTARY INFORMATION:

OMB Control No.: 3060-1060.

Title: Wireless E911 Coordination Initiative Letter.

Form No.: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: State, Local or Tribal Government.

Number of Respondents and Responses: 50 respondents; 50 responses.

Estimated Time per Response: 0.75 hours.

Frequency of Response: On occasion reporting requirement.

Obligation to Respond: Voluntary. Statutory authority for this collection is contained in Section 1 and 4(i) of the Communications Act.

Total Annual Burden: 38 hours.

Total Annual Cost: No cost.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: There is no need for confidentiality.

Needs and Uses: This collection will be submitted as an extension after this 60-day comment period to the Office of Management and Budget (OMB) in order to obtain the full three-year clearance. This voluntary collection was implemented in a letter that was sent, following the FCC's Second E911 Coordination Initiative, to pertinent State officials who had been appointed to oversee their States' programs to implement emergency (E911) Phase II service. This collection is necessary so that the Commission can correct inaccuracies and have up-to-date information to ensure the integrity of the Commission's database of Public Safety Answering Points (PSAPs) throughout the nation. The accurate compiling and maintaining of this database is an inherent part of the Commission's effort to achieve the expeditious implementation of E911 service across the nation and to ensure homeland security.

In accordance with the Federal Advisory Committee Act, Public Law 92-463 (Oct. 6, 1972), 5 U.S.C. App. 2, notice is hereby given of a meeting of the FDIC Advisory Committee on Community Banking, which will be held in Washington, DC. The Advisory Committee will provide advice and recommendations on a broad range of policy issues that have particular impact on small community banks throughout the United States and the local communities they serve, with a focus on rural areas.

DATES:

Thursday, November 3, 2016, from 9:00 a.m. to 3:00 p.m.

ADDRESSES:

The meeting will be held in the FDIC Board Room on the sixth floor of the FDIC Building located at 550 17th Street NW., Washington, DC.

FOR FURTHER INFORMATION CONTACT:

Requests for further information concerning the meeting may be directed to Mr. Robert E. Feldman, Committee Management Officer of the FDIC, at (202) 898-7043.

SUPPLEMENTARY INFORMATION:

Agenda: The agenda will include a discussion of current issues affecting community banking. The agenda is subject to change. Any changes to the agenda will be announced at the beginning of the meeting.

Type of Meeting: The meeting will be open to the public, limited only by the space available on a first-come, first-served basis. For security reasons, members of the public will be subject to security screening procedures and must present a valid photo identification to enter the building. The FDIC will provide attendees with auxiliary aids (e.g., sign language interpretation) required for this meeting. Those attendees needing such assistance should call (703) 562-6067 (Voice or TTY) at least two days before the meeting to make necessary arrangements. Written statements may be filed with the committee before or after the meeting. This Community Banking Advisory Committee meeting will be Webcast live via the Internet http://fdic.windrosemedia.com. Questions or troubleshooting help can be found at the same link. For optimal viewing, a high speed Internet connection is recommended. The Community Banking meeting videos are made available on-demand approximately two weeks after the event.

The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments on the agreements to the Secretary, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the Federal Register. Copies of the agreements are available through the Commission's Web site (www.fmc.gov) or by contacting the Office of Agreements at (202)-523-5793 or tradeanalysis@fmc.gov.

Synopsis: The amendment deletes APL Co. Pte. Ltd. and its subsidiary American President Lines, Ltd. as a separate member of the Agreement, and records it under CMA CGM S.A. to reflect the merger of the companies.

Synopsis: The amendment would authorize the parties to update the service on which COSCON provides slots to Zim in the trade between China and the U.S. West Coast, and provide for an expiration date of March 31, 2017. The parties have requested expedited review.

Synopsis: The amendment changes the name of the Agreement to the UASC/PIL Vessel Sharing Agreement—Asia and U.S. West Coast Services and deletes CMA CGM as a party to the Agreement. It also reflects the modified cooperation that will take place between UASC and PIL following CMA CGM's withdrawal from the Agreement.

Synopsis: The amendment deletes Malaysia, Panama, Saudi Arabia, Singapore, Sri Lanka, Taiwan, Vietnam, and the Gulf of Mexico, and adds South Korea and Panama to the geographic scope of the agreement. It also updates the services on which the parties provide space to each other.

The notificant listed below has applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).

The notice is available for immediate inspection at the Federal Reserve Bank indicated. The notice also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than November 3, 2016.

1. Otten Investments, LP, Norfolk, Nebraska, and Jarvis Otten, Norfolk, Nebraska individually and as general partners; to acquire additional shares and control of FEO Investments, Inc., and thereby acquire shares and control of Elkhorn Valley Bank & Trust, both in Norfolk, Nebraska.

The Board of Governors of the Federal Reserve System (Board or Federal Reserve) is adopting a proposal to revise, with extension for three years, the Annual Report of Holding Companies (FR Y-6), the Annual Report of Foreign Banking Organizations (FR Y-7), and the Report of Changes in Organizational Structure (FR Y-10). The revisions to the mandatory FR Y-6 and FR Y-7 information collections are effective with fiscal year-ends beginning December 31, 2016. The revisions to the mandatory FR Y-10 information collection are effective October 14, 2016.

On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.

The data collected in the FR Y-6, FR Y-7, FR Y-10, and FR Y-10E are not considered confidential. With regard to information that a banking organization may deem confidential, the institution may request confidential treatment of such information under one or more of the exemptions in the Freedom of Information Act (FOIA) (5 U.S.C. 552). The most likely case for confidential treatment will be based on FOIA exemption 4, which permits an agency to exempt from disclosure “trade secrets and commercial or financial information obtained from a person and privileged and confidential” (5 U.S.C. 552(b)(4)). To the extent an institution can establish the potential for substantial competitive harm, such information would be protected from disclosure under the standards set forth in National Parks & Conservation Association v. Morton, 498 F.2d 765 (D.C. Cir. 1974). Exemption 6 of FOIA might also apply with regard to the respondents' submission of non-public personal information of owners, shareholders, directors, officers and employees of respondents. Exemption 6 covers “personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy” (5 U.S.C. 552(b)(6)). All requests for confidential treatment would need to be reviewed on a case-by-case basis and in response to a specific request for disclosure.

The Federal Reserve proposes that the disclosure of the responses to the certification questions may interfere with home-country regulators' administration, execution, and disclosure of their stress-test regime and its results, and may cause substantial competitive harm to the FBO providing the information, and thus this information may be protected from disclosure under FOIA exemption 4.

Abstract: The FR Y-6 is an annual information collection submitted by top-tier HCs and non-qualifying FBOs. It collects financial data, an organization chart, verification of domestic branch data, and information about shareholders. The Federal Reserve uses the data to monitor HC operations and determine HC compliance with the provisions of the BHC Act, Regulation Y (12 CFR 225), the Home Owners' Loan Act (HOLA) and Regulation LL (12 CFR 238).

The FR Y-7 is an annual information collection submitted by qualifying FBOs to update their financial and organizational information with the Federal Reserve. The FR Y-7 collects financial, organizational, shareholder, and managerial information. The Federal Reserve uses the information to assess an FBO's ability to be a continuing source of strength to its U.S. operations and to determine compliance with U.S. laws and regulations.

The FR Y-10 is an event-generated information collection submitted by FBOs; top-tier HCs; securities holding companies as authorized under Section 618 of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 (the Dodd-Frank Act) (12 U.S.C. 1850a(c)(1)); state member banks unaffiliated with a bank holding company (BHC); Edge and agreement corporations that are not controlled by a member bank, a domestic BHC, or an FBO; and nationally chartered banks that are not controlled by a BHC (with regard to their foreign investments only), to capture changes in their regulated investments and activities. The Federal Reserve uses the data to monitor structure information on subsidiaries and regulated investments of these entities engaged in banking and nonbanking activities. The FR Y-10E is a free-form supplement that may be used to collect additional structural information deemed to be critical and needed in an expedited manner.

Current Actions: On April 25, 2016, the Federal Reserve published a notice in the Federal Register1 requesting public comment for 60 days on the proposal to revise, with extension, the FR Y-6, FR Y-7, FR Y-10, and FR Y-10E. Under the proposal, the revisions were to: (1) Modify the FR Y-6, FR Y-7, and FR Y-10 confidential treatment questions on reporting forms and instructions to align with the recently approved confidentiality check-box proposal,2 (2) modify the FR Y-7 and FR Y-10 to incorporate U.S. IHCs formed under the final rule for enhanced prudential standards for FBOs (Regulation YY),3 (3) clarifying the differences in reporting of additional companies by BHCs and Savings and Loan Holding Companies (SLHCs), adding a formula to calculate ownership percentage, and clarifying the signature requirements for employee stock ownership plans (ESOPs) and limited liability companies (LLCs), and (4) modify the FR Y-10 by removing the instructions for implementation of SLHCs from the General Instructions, removing the legal authority paragraph in the General Instructions, clarifying the instructions regarding the interest in sole partnership and sole member LLCs, separating the LAC for SLHCs into two codes, adding several new Glossary entries, and incorporating clarifying instructions that a nonbank subsidiary under a savings association does not meet the definition of a financial subsidiary. The comment period for this notice expired on June 24, 2016. The Federal Reserve received one comment letter from an industry association, which was outside the scope of the proposed changes. In addition, the Federal Reserve is extending the implementation date for the FR Y-10 to October 14, 2016.

1 81 FR 24101 (April 25, 2016).

2 80 FR 52282 (August 28, 2015).

3 The draft FR Y-6 reporting form and instructions associated with this proposal also include the language to collect information for U.S. IHCs of FBOs as discussed in the IHC proposal. See 81 FR 6265 (February 5, 2016) and 81 FR 35016 (June 1, 2016).

Detailed Discussion of Public Comments

The following is a detailed discussion of the comments and responses.

The commenter requested an electronic filing option for the FR Y-6 Organizational Chart. After review and consideration, the Federal Reserve will provide the option of submitting the FR Y-6 report as a PDF file in an email attachment to reduce burden. The instructions will be updated to reflect this change.

The commenter stated the method for validating Legal Entity Identifiers (LEIs) is inaccurate particularly for LEIs issued prior to 2012. While the validation method is accurate based on the current standards for issuing an LEI, the Federal Reserve believes it can be removed since the one-time collection for existing LEIs has been completed. Upon consideration of the comment, the Federal Reserve will remove the LEI validation from the FR Y-10 online application.

Although the proposal did not include amendments to item 10 or the definition of an LLC on the FR Y-10, the commenter requested guidance on how to report foreign entities for that line item in the FR Y-10 and suggested that a mapping document be provided, which would list foreign entities with their corresponding U.S. legal structure. Alternatively, the commenter made a number of suggestions regarding how LLCs, in particular, are reported on the form, and one suggestion was to modify the definition of LLC to clarify when a foreign entity should be reported as an LLC. After review and consideration, the Federal Reserve decided not to make these changes. Given the vast number of diverse organizational structures, the Federal Reserve believes that it is up to each respondent to apply judgement in determining whether a particular entity type fits within the legal entity structures listed in the form, including whether a foreign entity should be reported as an LLC. If a respondent determines that a business organization does not fit within any of the legal entity structures listed in the form, including the definition of LLC, it may report the legal entity as “Other” and provide a description of its unique characteristics.

The commenter requested clarification on how to report ownership interests in LLCs when the organization's governing documents are silent regarding the designation of a managing member and where an entity is designated as a manager (i.e., actively manages the day-to-day operation of the LLC), but has no ownership interest in the LLC. In addition, the commenter suggested that a flowchart be provided in the instructions to indicate how to report these interests. After review and consideration, the Federal Reserve decided not to make these changes. Since each respondent's relationship with the LLC will vary and the determination of whether to report its ownership interest as a managing or non-managing member may depend upon a combination of factors, including applicable state laws, the respondent should consult with its legal staff to take into account these unique facts and circumstances and report its interest in the manner it deems most appropriate.

The commenter requested an established and consistent process for withdrawing an erroneous FR Y-10 report that should not have been filed. The Federal Reserve support incorporating procedures for this process and will consider adding them as part of a future proposal.

Finally, the commenter requested several other technical enhancements to the FR Y-10 online application: (1) Establish a process for withdrawing an FR Y-10 report that should not have been filed, (2) add straight-through processing of the FR Y-10 either directly from internal systems or through a data load process, (3) add a notification that informs the reporter after an event has been processed, (4) add foreign branch entities, (5) remove restriction in the FR Y-10 online application to allow reporters that own interest in the same entity to report their holdings differently, and (6) update the RSSD search function. The Federal Reserve need additional time to investigate whether these enhancements are feasible and may consider them as a part of a future proposal as costs and resources permit.

The companies listed in this notice have given notice under section 4 of the Bank Holding Company Act (12 U.S.C. 1843) (BHC Act) and Regulation Y, (12 CFR part 225) to engage de novo, or to acquire or control voting securities or assets of a company, including the companies listed below, that engages either directly or through a subsidiary or other company, in a nonbanking activity that is listed in § 225.28 of Regulation Y (12 CFR 225.28) or that the Board has determined by Order to be closely related to banking and permissible for bank holding companies. Unless otherwise noted, these activities will be conducted throughout the United States.

Each notice is available for inspection at the Federal Reserve Bank indicated. The notice also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the question whether the proposal complies with the standards of section 4 of the BHC Act.

Unless otherwise noted, comments regarding the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than November 15, 2016.

The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.

Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than November 15, 2016.

1. Margaret Parker Platter Charitable Trust, Osceola, Missouri; to become a bank holding company by acquiring additional voting shares of SCC Bancshares, Inc., up to 26.03 percent, and thereby acquire shares of St. Clair County State Bank, both in Osceola, Missouri.

2. Sunflower Reincorporation Sub, Inc., Salina, Kansas; to merge with Strategic Growth Bank Incorporated, El Paso, Texas; Strategic Growth Bancorp Incorporated, and thereby acquire Capital Bank SSB, both in El Paso, Texas; and First National Bancorp Incorporated, and thereby acquire The First National Bank of Santa Fe, both in Albuquerque, New Mexico.

Description: The Personal Responsibility Education Program (PREP) grants provide education to adolescents on both abstinence and contraception for the prevention of pregnancy and sexually transmitted infections, including HIV/AIDS, as well as education on additional topics to prepare youth for adulthood. PREP programs are overseen by the Family and Youth Services Bureau (FYSB), in the Administration for Children and Families (ACF), in the U.S. Department of Health and Human Services (HHS).

The Promising Youth Programs (PYP) project supports PREP programming in two ways. First, it supports grantees as they collaborate with independent evaluators to conduct evaluations of their programs. Second, it is working to develop curricula for underserved youth. PYP is overseen by ACF's Office of Planning, Research, and Evaluation (OPRE). To support the PYP project, FYSB and OPRE seek approval to collect the following information:

(1) Abstract template: We will annually ask grantees and their independent evaluators to develop/update abstracts about their programs/evaluations.

(2) CONSORT (CONsolidated Standards Of Reporting Trials) diagram template: We will bi-annually ask grantees and their independent evaluators for information about study recruitment, enrollment, and retention.

(3) Baseline equivalence template: We will bi-annually ask grantees and their independent evaluators for information that demonstrates whether program and comparison groups are comparable.

(4) Implementation analysis plan template: In Year 2 of their grants we will ask grantees and their independent evaluators for information that outlines their implementation analysis plans.

(5) Youth discussions topic guide: We will hold discussions with youth from target populations about their perceptions of PREP-related programming.

Respondents: We will ask grantees and their independent evaluators for information related to (1), (2), (3), and (4). We will ask youth from target populations for information related to (5).

Annual Burden Estimates[3 year information collection]InstrumentTotal number of respondentsAnnual

In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington, DC 20201, Attn: OPRE Reports Clearance Officer. Email address: OPREinfocollection@acf.hhs.gov. All requests should be identified by the title of the information collection.

The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.

The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Submit written comments on the collection of information by November 18, 2016.

ADDRESSES:

Submit written comments on the collection of information by fax 202.395.5806 or by email to OIRA_submission@omb.eop.gov, Attn: OMB Desk Officer for ACL.

In compliance with 44 U.S.C. 3507, AoA has submitted the following proposed collection of information to OMB for review and clearance.

States provide the following data and narrative information in the report:

1. Numbers and descriptions of cases filed and complaints made on behalf of long-term care facility residents to the statewide ombudsman program;

2. Major issues identified that impact the quality of care and life of long-term care facility residents;

3. Statewide program operations; and

4. Ombudsman activities in addition to complaint investigation.

5. A new requirement to include organizational conflict of interest reporting as required by the reauthorized Older Americans Act and the LTC Ombudsman program rule at 45 CFR 1324.21.

The report form and instructions have been in continuous use, with minor modifications, since they were first approved by OMB for the FY 1995 reporting period. This current request is for a Revision of a Currently Approved Collection (ICR Rev), which will provide approval for FFY 2016-2018 with modifications to include organizational conflict of interest reporting as required by the reauthorized Older Americans Act, Section 712(f) and the LTC Ombudsman program rule at 45 CFR 1324.21.

The data collected on complaints filed with ombudsman programs and narrative on long-term care issues provide information to Centers for Medicare and Medicaid Services and others on patterns of concerns and major long-term care issues affecting residents of long-term care facilities. Both the complaint and program data collected assist the states and local ombudsman programs in planning strategies and activities, providing training and technical assistance and developing performance measures.

Comments in Response to the 60 Day Federal Register Notice

A notice was published in the Federal Register/Vol. 81, No. 126/Thursday, June 30, 2016 Notices, Pages 42712-42713, announcing that AoA was requesting modification of the current form and instructions to incorporate conflict of interest reporting requirements, directing readers to the AoA Web site where these documents are posted and providing an opportunity for public comment. One comment was received from the National Association of Ombudsman Programs (NASOP).

NASOP members disagreed with the burden estimate developed by AoA, stating: Because an overwhelming majority of state long-term care ombudsman programs designate local ombudsman entities, those circumstances lead to a greater likelihood of organizational conflicts of interest. The burden is compounded by the number of local ombudsman entities within a state and will have multiple sources of reporting organizational conflicts at local or regional levels up to the states before states can report via NORS. Further, because approximately half of state long-term care ombudsman programs are housed within an umbrella agency, this also increases the likelihood that state programs have multiple organizational conflicts that must be identified, remedied or removed, and reported via NORS.

In response to NASOP's concerns about burden estimates, we made a change in our estimated burden hours from one-half hour per state to one hour per state.

NASOP requested additions to the instructions and report form such as the ability to certify that there was no change in conflicts/remedies from the previous reporting year; and to allow for the ability to report a conflict and remedy that applies to many entities as a reporting entry. These suggestions were helpful and were incorporated into the instructions and form. They did not affect the estimated burden.

NASOP also recommended that AoA/ACL add a reporting option in a check box to indicate a state has identified a conflict, but the conflict has not been remedied. We do not intend to take this recommendation because it would be contrary to the rule and law which require states to identify, remove or remedy conflicts and to report on such remedies. ACL is providing on-going technical assistance to states on the implementation of the Ombudsman program rule, including technical assistance on conflicts of interest and steps to remedy any identified conflicts.

A reporting form and instructions may be viewed in the ombudsman section of the AoA Web site: http://www.aoa.acl.gov/AoA_Programs/Elder_Rights/Ombudsman/index.aspx. AoA estimates the burden of this collection and entering the additional report information as follows: Approximately 10 to 60 minutes per respondent, depending on the number of conflicts to report, with 52 state Ombudsman programs responding annually. This brings the total burden hours to approximately 7,753 hours, (149 hours on average per program) with 52 Offices of Long-Term Care Ombudsman programs responding annually.

The Food and Drug Administration (FDA) is establishing a public docket to receive input on emerging issues and cross-cutting scientific advances that may impact FDA preparedness and inter-Agency activities. Interested parties are invited to submit comments regarding emerging technologies and cross-cutting scientific advances of importance to FDA. The focus is on areas that may impact FDA in 5 or more years.

DATES:

Submit either electronic or written comments by October 21, 2019.

ADDRESSES:

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2016-N-2406 for “Emerging Issues and Cross-Cutting Scientific Advances.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our Nation's food supply, cosmetics, and products that emit radiation. FDA is tasked with advancing the public health by helping to speed innovations that protect the public health. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products, to protect the public health, and to reduce tobacco use by minors. Finally, FDA plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply, and by fostering development of medical products used to respond to deliberate and naturally emerging public health threats.

FDA's ability to achieve its mission relies on awareness of, and proactive preparedness for, emerging issues and scientific advances, which will impact the development of regulated products well in advance of formal FDA regulatory submissions (e.g., 5-10 years). To realize this goal requires long-range horizon scanning by a cadre of scientific leaders from FDA, other government Agencies, interested stakeholders, and the public. Emerging sciences, such as synthetic biology, are expected to impact FDA regulated products in the relatively near term. The goal of this initiative is to identify issues and advances that will impact the Agency in the longer term and thus may be in their infancy.

FDA formed the Emerging Sciences Working Group to provide an FDA-wide science-based forum to identify and communicate scientific regulatory approaches, in order to prepare for anticipated high impact emerging science and technology. Additionally, the Emerging Sciences Working Group informs and advises Agency and FDA Center leadership on critical and cross-cutting issues likely to impact regulatory policy development.

The Emerging Sciences Working Group is seeking input from the public to identify emerging science and technology. Results from long range horizon scanning will assist FDA regarding emerging issues and cross-cutting scientific advances, which may impact FDA preparedness in the future.

The Food and Drug Administration (FDA) has determined the regulatory review period for REPATHA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

DATES:

Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by December 19, 2016. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by April 17, 2017. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES:

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket Nos. FDA-2016-E-0463, FDA-2016-E-0532, and FDA-2016-E-2468 for “Determination of Regulatory Review Period for Purposes of Patent Extension; REPATHA.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human biologic product REPATHA (evolocumab). REPATHA is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of low density lipoprotein cholesterol (LDL-C) or as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia who require additional lowering of LDL-C. Subsequent to this approval, the USPTO received patent term restoration applications for REPATHA (U.S. Patent Nos. 8,030,457; 8,829,165; and 8,981,064) from Amgen Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated April 29, 2016, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of REPATHA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

FDA has determined that the applicable regulatory review period for REPATHA is 2,267 days. Of this time, 1,901 days occurred during the testing phase of the regulatory review period, while 366 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: June 14, 2009. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on June 14, 2009.

2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): August 27, 2014. FDA has verified the applicant's claim that the biologics license application (BLA) for REPATHA (BLA 125522) was initially submitted on August 27, 2014.

3. The date the application was approved: August 27, 2015. FDA has verified the applicant's claim that BLA 125522 was approved on August 27, 2015.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 895 days, 353 days, or 164 days of patent term extension, respectively.

III. Petitions

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

The Food and Drug Administration (FDA) has determined the regulatory review period for PRILOSEC OTC and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

DATES:

Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by December 19, 2016. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by April 17, 2017. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES:

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2004-E-0463 for “Determination of Regulatory Review Period for Purposes of Patent Extension; PRILOSEC OTC.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human drug product PRILOSEC OTC (omeprazole magnesium). PRILOSEC OTC is indicated for treatment of frequent heartburn for consumers 18 years of age and older. Subsequent to this approval, the USPTO received a patent term restoration application for PRILOSEC OTC (U.S. Patent No. 5,817,338) from AstraZeneca AB, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated October 19, 2004, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of PRILOSEC OTC represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

FDA has determined that the applicable regulatory review period for PRILOSEC OTC is 2,045 days. Of this time, 804 days occurred during the testing phase of the regulatory review period, while 1,241 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: November 15, 1997. The applicant claims November 14, 1997, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was November 15, 1997, which was 30 days after FDA receipt of the IND.

2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: January 27, 2000. FDA has verified the applicant's claim that the new drug application (NDA) for PRILOSEC OTC (NDA 21-229) was initially submitted on January 27, 2000.

3. The date the application was approved: June 20, 2003. FDA has verified the applicant's claim that NDA 21-229 was approved on June 20, 2003.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 623 days of patent term extension.

III. Petitions

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

The Food and Drug Administration (FDA) has determined the regulatory review period for PLEGRIDY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

DATES:

Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by December 19, 2016. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by April 17, 2017. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES:

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket Nos. FDA-2015-E-2780; FDA-2015-E-2778; and FDA-2015-E-2779 for “Determination of Regulatory Review Period for Purposes of Patent Extension; PLEGRIDY.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human biologic product PLEGRIDY (peginterferon beta-1a). PLEGRIDY is indicated for treatment of patients with relapsing forms of multiple sclerosis. Subsequent to this approval, the USPTO received patent term restoration applications for PLEGRIDY (U.S. Patent Nos. 7,446,173; 8,017,733; and 8,524,660) from Biogen Idec MA Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated October 15, 2015, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of PLEGRIDY represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

FDA has determined that the applicable regulatory review period for PLEGRIDY is 2,643 days. Of this time, 2,186 days occurred during the testing phase of the regulatory review period, while 457 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: May 23, 2007. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on May 23, 2007.

2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): May 16, 2013. FDA has verified the applicant's claim that the biologics license application (BLA) for PLEGRIDY (BLA 125499) was initially submitted on May 16, 2013.

3. The date the application was approved: August 15, 2014. FDA has verified the applicant's claim that BLA 125499 was approved on August 15, 2014.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,284 days, 762 days, or 346 days of patent term extension, respectively.

III. Petitions

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on requirements for premarket approval of medical devices.

DATES:

Submit either electronic or written comments on the collection of information by December 19, 2016.

ADDRESSES:

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal:http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2013-N-0825 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Premarket Approval of Medical Devices—21 CFR part 814—OMB Control Number 0910-0231—Extension

Under section 515 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e) all devices placed into class III by FDA are subject to premarket approval requirements. Premarket approval (PMA) is the process of scientific and regulatory review to ensure the safety and effectiveness of class III devices. An approved PMA is, in effect, a private license granted to the applicant for marketing a particular medical device. A class III device that fails to meet PMA requirements is considered to be adulterated under section 501(f) of the FD&C Act 21 U.S.C. 351(f)) and cannot be marketed. Premarket approval requirements apply differently to preamendments devices, postamendments devices, and transitional class III devices.

Manufacturers of class III preamendments devices, devices that were in commercial distribution before May 28, 1976, are not required to submit a PMA until 30 months after the issuance of a final classification regulation or until 90 days after the publication of a final regulation requiring the submission of a PMA, whichever period is later. FDA may allow more than 90 days after issuance of a final rule for submission of a PMA.

A postamendments device is one that was first distributed commercially on or after May 28, 1976. Postamendments devices determined by FDA to be substantially equivalent to preamendments class III devices are subject to the same requirements as the preamendments devices. FDA determines substantial equivalence after reviewing an applicant's premarket notification submitted in accordance with section 510(k) of the FD&C Act (21 U.S.C. 360(k)). Postamendments devices determined by FDA to be not substantially equivalent to either preamendments devices or postamendments devices classified into class I or II are “new” devices and fall automatically into class III. Before such devices can be marketed, they must have an approved premarket approval application or be must reclassified into class I or class II.

The Food and Drug Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) was enacted on November 21, 1997, to implement revisions to the FD&C Act by streamlining the process of bringing safe and effective drugs, medical devices, and other therapies to the U.S. market. FDAMA added section 515(d)(6) to the FD&C Act, which provided that PMA supplements were required for all device changes that affect safety and effectiveness unless such changes are modifications to manufacturing procedures or method of manufacture. That type of manufacturing change will require a 30-day notice, or where FDA finds such notice inadequate, a 135-day PMA supplement.

The implementing regulations, contained in part 814 (21 CFR part 814), further specify the contents of a PMA for a medical device and the criteria FDA will employ in approving, denying, or withdrawing approval of a PMA and supplements to PMAs. The regulations' purpose is to establish an efficient and thorough procedure for FDA's review of PMAs and supplements to PMAs for class III medical devices. The regulations facilitate the approval of PMAs and supplements to PMAs for devices that have been shown to be reasonably safe and effective and otherwise meet the statutory criteria for approval. The regulations also ensure the denial of PMAs and supplements to PMAs for devices that have not been shown to be reasonably safe and effective and that do not otherwise meet the statutory criteria for approval.

The industry-wide burden estimate for PMAs is based on an FDA average fiscal year (FY) annual rate of receipt of PMA submissions data FY 2013 through 2015 and our expectation of submissions to come in the next few years. The burden data for PMAs is based on data provided by applicants by device type and cost element in an earlier study.

Reporting Burden: The reporting burden can be broken out by certain sections of the PMA regulations and the FD&C Act as follows:

§ 814.15(b)—Research Conducted Outside the United States. Each foreign study should be performed in accordance with the “Declaration of Helsinki” or the laws and regulations of the country in which the study was conducted. If the study was conducted in accordance with the laws of the country, the PMA applicant is required to explain to FDA in detail the differences between the laws of the country and the “Declaration of Helsinki.” Based on the number of PMAs received that contained studies from overseas, FDA estimates that the burden estimate necessary to meet this requirement is 50 hours.

§ 814.20—Application. Included in this requirement are the conduct of laboratory and clinical trials as well as the analysis, review, and physical preparation of the PMA application. FDA estimates that 35 applicants, including hospital re-manufacturers of single-use devices, will be affected by these requirements which are based on the actual average of FDA receipt of new PMA applications in FY 2013 through 2015. FDA's estimate of the hours per response (668) was derived through FDA's experience and consultation with industry and trade associations. In addition, FDA also based its estimate on the results of an earlier study that accounts for the bulk of the hourly burden for this requirement, which is identified by applicants.

§ 814.37(a) through (c) and (e)—PMA Amendments and Resubmitted PMAs. As part of the review process, FDA often requests the PMA applicant to submit additional information regarding the device necessary for FDA to file the PMA or to complete its review and make a final decision. The PMA applicant may, also on their own initiative, submit additional information to FDA during the review process. These amendments contain information ranging from additional test results, re-analysis of the original data set, to revised device labeling. Almost all PMAs received by the Agency have amendments submitted during the review process.

§ 814.39(d)—Special PMA Supplements—Changes Being Affected. This type of supplement is intended to enhance the safety of the device or the safe use of the device. The number of PMA supplements received that fit this category averaged 88 per year based on the numbers received from FY 2013 through FY 2015. Because of the minimal data required to be included in this type of supplement, FDA estimates that the burden hours necessary to satisfy this requirement are 528 hours.

§ 814.39(f)—30-Day Notice. Under section 515(d) of the FD&C Act, modifications to manufacturing procedures or methods of manufacture that affect the safety and effectiveness of a device subject to an approved PMA do not require submission of a PMA supplement under paragraph (a) of this section and are eligible to be the subject of a 30-day notice. A 30-day notice shall describe in detail the change, summarize the data or information supporting the change, and state that the change has been made in accordance with the requirements of part 820 (21 CFR part 820). The applicant may distribute the device 30 days after the date on which FDA receives the 30-day notice, unless FDA notifies the applicant within 30 days from receipt of the notice, that it is not adequate.

§ 814.82(a)(9)—Postapproval Requirements. Postapproval requirements concerns approved PMAs that were not reclassified and require a periodic report. After approval, all PMAs require a submission of an annual report. A majority of the submitted PMAs require associated postapproval studies, i.e., followup of patients used in clinical trials to support the PMA or additional preclinical information that is labor-intensive to compile and complete; the remaining PMAs require minimal information.

§ 814.84(b)—Periodic Reports. Postapproval requirements described in § 814.82(a)(7) require submission of an annual report for each approved PMA. FDA estimates that respondents will average about 10 hours in preparing their reports to meet this requirement. This estimate is based on FDA's experience and consultation with industry.

Expedited or Priority Review—Section 515(d)(5) of the FD&C Act. FDA will provide special review, which can include expedited processing of a PMA application, for certain devices intended to treat or diagnose life threatening or irreversibly debilitating diseases or conditions. To receive special review, the devices must meet one of the following criteria:

• The device represents a breakthrough technology;

• There are no approved alternatives;

• The use of the device offers significant advantages over existing approved alternatives;

• Availability is in the best interest of the patients.

Agreement Meeting—Section 520(g)(7) of the FD&C Act (21 U.S.C. 360j(g)(7)). Applicants planning to submit a PMA may submit a written request to reach agreement with FDA on the key parameters of the investigational plan.

Determination Meeting—Section 513(a)(3)(D) of the FD&C Act (21 U.S.C. 360c(a)(3)(D)). Applicants planning to submit a PMA may submit a written request to FDA for a meeting to determine the type of information (valid scientific evidence) necessary to support the effectiveness of their device.

Panel of Experts—Section 515(c)(3) of the FD&C Act. An original PMA or panel track PMA supplement is taken to an advisory panel of experts unless FDA determines that the information in the application substantially duplicates information which has previously been reviewed by the panel.

Day 100 Meeting—Section 515(d)(3) of the FD&C Act. FDA must, upon the written request of the applicant, meet with that party within 100 days of receipt of the filed PMA application to discuss the review status of the application. With the concurrence of the applicant, a different schedule may be established. Prior to this meeting, FDA must inform the applicant in writing of any identified deficiencies and what information is required to correct those deficiencies. FDA must also promptly notify the applicant if FDA identifies additional deficiencies or of any additional information required to complete Agency review.

Recordkeeping

§ 814.82(a)(5) and (a)(6)—Maintenance of Records. The recordkeeping burden under this section requires the maintenance of records, used to trace patients and the organization and indexing of records into identifiable files to ensure the device's continued safety and effectiveness. These records are required of all applicants who have an approved PMA.

PMAs have been required since 1976, and there are 725 active PMAs that could be subject to these requirements, based on actual FDA data, and approximately 30 new PMAs are approved every year. The aggregate burden for the estimated 422 PMA holders of approved original PMAs for the next few years is estimated to be 7,174 hours.

The applicant determines which records should be maintained during product development to document and/or substantiate the device's safety and effectiveness. Records required by the current good manufacturing practices for medical devices regulation (21 CFR part 820) may be relevant to a PMA review and may be submitted as part of an application. In individual instances, records may be required as conditions of approval to ensure the device's continuing safety and effectiveness.

FDA estimates the burden of this collection of information as follows:

Total hoursMaintenance of records (814.82(a)(5) and (a)(6))4221422177,1741 There are no capital costs or operating and maintenance costs associated with this collection of information.Dated: October 13, 2016.Leslie Kux,Associate Commissioner for Policy.[FR Doc. 2016-25232 Filed 10-18-16; 8:45 am] BILLING CODE 4164-01-PDEPARTMENT OF HEALTH AND HUMAN SERVICESSolicitation for Applications From Individuals Interested in Being Appointed to the Chronic Fatigue Syndrome Advisory CommitteeAGENCY:

Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health.

ACTION:

Notice.

Authority:

42 U.S.C. 217a, Section 222 of the Public Health Service Act, as amended. The Committee is governed by the provisions of Public Law 92-463, as amended (5 U.S.C. App. 2), which sets forth standards for the formation and use of advisory committees.

SUMMARY:

The Office of the Assistant Secretary for Health (OASH), within the Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). CFSAC provides advice and recommendations to the Secretary of HHS, through the Assistant Secretary for Health (ASH), on a broad range of issues and topics related to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The appointments of two Committee members are scheduled to end during the 2016 calendar year. Nominations of qualified candidates are being sought to fill the positions that are scheduled to be vacated.

DATES:

Applications for individuals to be considered for appointment to the Committee must be received no later than 5 p.m. EDT on November 18, 2016 at the address listed below.

CFSAC was established on September 5, 2002. The purpose of the CFSAC is to provide advice and recommendations to the Secretary of HHS, through the ASH, on issues related to ME/CFS. The CFSAC advises and makes recommendations on a broad range of topics including: (1) Opportunities to improve knowledge and research about the epidemiology, etiologies, biomarkers and risk factors for ME/CFS; (2) research on the diagnosis, treatment, and management of ME/CFS and potential impact of treatment options; (3) strategies to inform the public, health care professionals, and the biomedical academic and research communities about ME/CFS advances; (4) partnerships to improve the quality of life of ME/CFS patients; and (5) strategies to insure that input from ME/CFS patients and caregivers is incorporated into HHS policy and research. The CFSAC charter is available at: http://www.hhs.gov/advcomcfs/charter/index.html. Management and support services for Committee activities are provided by staff from within the OASH. The ASH provides direction and guidance for services performed to support CFSAC activities and operation.

Nominations: OASH is requesting nominations to fill CFSAC positions scheduled to be vacated at the end of 2016. The Committee composition consists of seven scientists with demonstrated expertise in biomedical research applicable to ME/CFS, four individuals with demonstrated expertise in health care delivery, private health care services, insurance, and three patients/care givers of ME/CFS. The vacant positions are in the biomedical research category. Individuals selected for appointment to the Committee will serve as voting members and may be invited to serve terms of up to four years.

CFSAC members are authorized to receive a stipend for conducting Committee related business, including attending Committee meetings. Committee members also are authorized to receive per diem and reimbursement for travel expenses incurred for conducting Committee related business. To qualify for consideration of appointment to the Committee, an individual must possess demonstrated experience and knowledge in the designated fields or disciplines, as well as expert knowledge of the broad issues and topics pertinent to ME/CFS.

Nomination materials should be typewritten. If mailed, please submit original documents. The nomination materials should be submitted (postmarked or received) no later than 5:00 p.m. EDT on the specified date. The following information must be part of the nomination package submitted for each individual being nominated: (1) A letter of nomination that clearly states the name and affiliation of the nominee, the basis for the nomination (i.e., specific attributes which qualify the nominee for service in this capacity), and a statement that the nominee is willing to serve as a member of the Committee; (2) the nominator's name, address, and daytime telephone number; (3) the home and/or work address, telephone number, and email address of the individual being nominated; and (4) a current copy of the nominee's curriculum vitae or resume, which should not exceed 10 pages. An individual may self-nominate. Federal employees should not be nominated for consideration of appointment to this Committee. Nominations that do not contain all of the above information will not be considered.

Electronic submissions: Nomination materials, including attachments, may be submitted electronically to cfsac@hhs.gov.

Appointment to the Committee is made by the Secretary of HHS. The Department makes every effort to ensure that the membership of federal advisory committees is fairly balanced in terms of points of view represented. Every effort is made to ensure that a broad representation of geographic areas, females, ethnic and minority groups, and people with disabilities are given consideration for membership on federal advisory committees. Appointment to this Committee shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, disability, and cultural, religious, or socioeconomic status. Nominations must state that the nominee is willing to serve as a member of CFSAC and appears to have no conflict of interest that would preclude membership. Candidates who are selected for appointment to the Committee are required to provide detailed information concerning such matters as financial holdings, consultancies, and research grants or contracts for an ethics analysis to be conducted to identify potential conflicts of interest.

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Board of Scientific Counselors, National Human Genome Research Institute.

The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the NATIONAL HUMAN GENOME RESEARCH INSTITUTE, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: Board of Scientific Counselors, National Human Genome Research Institute.

Date: November 1-2, 2016.

Time: November 1, 2016, 6:00 p.m. to 9:30 p.m.

Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators.

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

The Substance Abuse and Mental Health Services Administration (SAMHSA) is requesting approval for a revision to the data collection associated with the SAMHSA Disaster Technical Assistance Center (DTAC) Disaster Behavioral Health Needs Assessment and Customer Satisfaction Surveys (OMB No. 0930-0325), which expire on May 31, 2017. Specifically, SAMHSA DTAC plans to consolidate the Needs Assessment Survey and Customer Satisfaction Surveys into a single instrument. The new revised instrument, entitled SAMHSA DTAC Customer Feedback Survey (CFS), under this effort will also include a change in administration to make it appropriate for a single, streamlined survey.

The proposed data collection effort will provide feedback on the overall effectiveness of SAMHSA DTAC's services, ongoing needs at the national level, and areas that require enhanced technical assistance (TA) services.

SAMHSA DTAC will be responsible for administering the data collection instrument and analyzing the data. SAMHSA DTAC will use data from the instrument to inform current and future TA activities and to ensure these activities continue to align with state and local needs.

A three-year clearance is being requested. The SAMHSA DTAC CFS is designed to allow the agency to collect feedback on the overall effectiveness of the services provided by SAMHSA DTAC, as well as ongoing data regarding disaster behavioral health (mental health and substance use-related) needs at the national level and areas that require enhanced training and technical assistance (TA) services. This is the information that was previously collected as part of the SAMHSA DTAC Needs Assessment Survey (NAS) and Customer Satisfaction Survey (CSS). Data from this effort will continue to be used to improve services to jurisdictions, which will lead to (1) better integration of disaster behavioral health (DBH) needs with all-hazards disaster preparedness and response, and (2) improved outcomes at the state, territory, tribal, and local levels with less burden on participants. The new Customer Feedback Survey integrates and consolidates questions from the previously utilized NAS and CSS, which will reduce burden associated with the number of instruments and survey questions. SAMHSA DTAC will continue to be responsible for survey administration and analysis of the data collected, which SAMHSA will use to inform current and future training and TA activities. Table 1 shows the estimated burden associated with CFS data collection activities and the associated costs. It is anticipated that the survey will be administered once each year.

Participation in the Customer Feedback Survey will be solicited from all 50 states, the U.S. territories, and the District of Columbia. The survey will be administered to individuals who have requested TA within the six months prior to administration and those who are subscribed to DTAC's e-communications, SAMHSA DTAC Bulletin, or The Dialogue, at the time of administration. Internet-based technology will be used to collect data via web-based survey for data entry and management.

Table 1—Annualized Estimate of Respondent BurdenType of respondentInstrumentNumber of

Written comments and recommendations concerning the proposed information collection should be sent by November 18, 2016 to the SAMHSA Desk Officer at the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB). To ensure timely receipt of comments, and to avoid potential delays in OMB's receipt and processing of mail sent through the U.S. Postal Service, commenters are encouraged to submit their comments to OMB via email to: OIRA_Submission@omb.eop.gov. Although commenters are encouraged to send their comments via email, commenters may also fax their comments to: 202-395-7285. Commenters may also mail them to: Office of Management and Budget, Office of Information and Regulatory Affairs, New Executive Office Building, Room 10102, Washington, DC 20503.

In accordance with the Privacy Act of 1974, the Department of Homeland Security (DHS) proposes to update and reissue a current DHS system of records titled, “DHS/United States Citizenship and Immigration Services (USCIS)-007 Benefit Information System” system of records. DHS/USCIS collects, uses, and maintains the Benefit Information System records to administer immigrant or nonimmigrant benefit requests, “hereinafter collectively referred to as “benefit requests” ” to process and adjudicate all benefit requests submitted for naturalization, lawful permanent residence, asylum, refugee status, and other immigrant and nonimmigrant benefits in accordance with U.S. immigration law. DHS/USCIS also uses the Benefit Information System to support national security by preventing individuals from fraudulently obtaining immigration benefits and by denying benefit requests submitted by individuals who pose national security or public safety threats. This system of records notice was previously published in the Federal Register on September 29, 2008, (73 FR 56596).

DHS/USCIS is updating this system of records to: (1) Update the system location to include international offices and replicated copies on unclassified and classified networks; (2) update the category of individuals to include interpreters, preparers, physicians, and sponsors; (3) expand the categories of records to clarify the data elements that USCIS collects from benefit requestors, beneficiaries, and family members', benefit sponsors; representatives; preparers and interpreters; and physicians; (4) separate routine use (N) into two separate routine uses (i.e., (N), (O)) to provide clarity on information sharing with federal, state, tribal, or local government agencies and foreign government agencies for the repayment of loans; (5) update routine uses (W), (X), (Y), and (Z) to permit the sharing of information pursuant to a Computer Matching Agreement or other agreement, with the Department of Labor, with the public during the course of naturalization ceremonies, and with the Department of Treasury, respectively; (6) update retention schedules for each record type; (7) expand data elements used to retrieve records from the elements listed or a combination thereof; (8) update sources of records to include interpreters, preparers, and physicians; and (9) expand the system classification to provide notice that Benefit Information System records may be stored on both DHS unclassified and classified networks to allow for analysis and vetting consistent with existing DHS/USCIS authorities and purposes and this published notice. Additionally, this notice includes non-substantive changes to simplify the formatting and text of the previously published notice.

This updated system will be included in the Department of Homeland Security's inventory of record systems.

DATES:

Submit comments on or before November 17, 2016. This updated system will be effective November 17, 2016.

ADDRESSES:

You may submit comments, identified by docket number DHS-2016-0043 by one of the following methods:

All submissions received must include the agency name and docket number for this rulemaking. All comments received will be posted without change to http://www.regulations.gov, including any personal information provided.

DOCKET:

For access to the docket to read background documents or comments received, please visit http://www.regulations.gov.

In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, the Department of Homeland Security (DHS) United States Citizenship and Immigration Services (USCIS) proposes to update and reissue a current DHS system of records titled, “DHS/USCIS-007 Benefit Information System” system of records.

DHS/USCIS oversees lawful immigration and non-immigration to the United States and is responsible for the administration of immigration, non-immigration, and naturalization adjudication functions and for establishing immigration policies and priorities. In executing its mission, DHS/USCIS performs functions that include the intake, review, and adjudication of the following types of benefits:

(1) Family-Based; 1

1 An individual may petition for relatives (or future relatives such as a fiancé(e) or a prospective adopted child) to immigrate to the United States.

(2) Employment-Based; 2

2 All foreign workers must obtain permission to work legally in the United States. Each employment category for admission has different requirements, conditions, and authorized periods of stay. USCIS offers the following employment-based categories: Temporary (nonimmigrant) worker, permanent workers, students and exchange visitors, and temporary visitors for business.

(3) Humanitarian-Based; 3

3 USCIS provides a number of humanitarian programs and protection to assist individuals in need of shelter or aid from disasters, from oppression, for emergency medical issues, and for other urgent circumstances, including: Asylum; refugee; parole; deferred action; temporary protective status; battered spouse, children, and parents; and victims of human trafficking and other crimes.

(4) Adoption-Based; 4 and

4 USCIS is responsible for determining the eligibility and suitability of the Prospective Adoptive Parents (individuals) looking to adopt and determining the eligibility of the child to immigrate to the United States.

(5) Citizenship and Naturalization-Based.5

5 Naturalization is the manner in which a person not born in the United States voluntarily becomes a U.S. citizen.

The Benefits Information System SORN covers the processing of immigrant and nonimmigrant benefit requests and does not cover requests for asylum and refugee status. The Benefits Information System includes: Information provided by or on behalf of individuals who submit immigrant and nonimmigrant benefit requests; background check results collected as part of the USCIS-initiated background check process; and transactional data that indicates which steps of the adjudication process have been completed, such as an appointment to submit biometrics for a background check, other pending benefits, whether the benefit requestor may have engaged in fraudulent activity, or activities that adversely impact the national security or public safety of the United States that could bear on fitness or eligibility for the requested benefits.

Records covered by this Benefit Information System (BIS) SORN differ from records covered by the Alien File (A-File), Index, and National File Tracking SORN (see DHS/USCIS/ICE/CBP-001 Alien File, Index, and National File Tracking System of Records, November 21, 2013, 78 FR 69864). The A-File is the official record regarding the transactions of an individual as he or she passes through the U.S. immigration and inspection process. The A-File contains information relating to immigration benefits processing, protection of national security, and administering and enforcing immigration and nationality laws and related statutes. While USCIS is the custodian of the A-File, the three former Immigration and Naturalization Service (INS) agencies: USCIS, U.S. Customs and Border Protection (CBP), and U.S. Immigrations and Customs Enforcement (ICE), all contribute information to and use A-Files. The A-File SORN covers the paper and electronic copy A-File and/or Receipt File, supplemental forms, supplemental evidence, and identity history summaries (formally known as RAP sheets), but does not include all case processing and decisional data. The BIS SORN is specific to USCIS' collection, use, maintenance, dissemination, and storage of benefit request information, including case processing and decisional data not included in the A-file. USCIS records case processing information such as date USCIS received or filed benefit requests; benefit request status; location of record; other control number when applicable; fee receipt data; status of USCIS appointments and interviews; date of issuance of a notice; and whether the benefit request form was referred to the Fraud Detection and National Security Directorate for review. Decisional data such as approval/denial code is also stored in the BIS SORN.

USCIS is updating this system of records to (1) update system location to include international offices; (2) update category of individuals covered by this SORN, to include interpreters, preparers, and physicians, and sponsors; (3) expand the categories of records to clarify the data elements that USCIS collects from benefit requestors, beneficiaries, and family members; benefit sponsors; representatives; preparers and interpreters; and physicians; (4) separate routine use (N) has been separated into two separate routine uses (i.e., (N), (O)) to provide clarity on information sharing of information with federal, state, tribal, or local government agencies and foreign government agencies for the, respectively, in collecting the repayment of loans; later routine uses are being re-lettered for formatting; (5) update routine uses (W), (X), (Y), and (Z) to permit the sharing of information pursuant to a Computer Matching Agreement or other agreement, with the Department of Labor, with the public during the course of naturalization ceremonies, and with the Department of Treasury, respectively; (6) update retention schedules for each record type; (7) expand data elements used to retrieve records from the elements listed or a combination thereof; (8) update sources of records to include interpreters, preparers, and physicians; (9) expand the system classification to provide notice that Benefit Information System records may be stored on both DHS unclassified and classified networks to allow for analysis and vetting consistent with existing DHS/USCIS authorities and purposes and this published notice. Furthermore, this notice includes non-substantive changes to simplify the formatting and text of the previously published notice.

Consistent with DHS's information sharing mission, information stored in the DHS/USCIS-007 Benefit Information System may be shared with other DHS components that have a need to know the information to carry out their national security, law enforcement, immigration, intelligence, or other homeland security functions. In addition, DHS/USCIS may share information with appropriate federal, state, local, tribal, territorial, foreign, or international government agencies consistent with the routine uses set forth in this system of records notice. Even when a valid routine use permits disclosure of information from this system of records to a third party, in some cases such disclosure may not be permissible because of confidentiality laws and policies that limit the sharing of information regarding individuals applying for certain immigration or non-immigration benefits.

This updated system will be included in DHS's inventory of record systems.

II. Privacy Act

The Privacy Act embodies fair information practice principles in a statutory framework governing the means by which federal government agencies collect, maintain, use, and disseminate individuals' records. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to the individual. In the Privacy Act, an individual is defined to encompass U.S. citizens and lawful permanent residents. As a matter of policy, DHS extends administrative Privacy Act protections to all individuals when systems of records maintain information on U.S. citizens, lawful permanent residents, and visitors.

Below is the description of the DHS/USCIS-007 Benefit Information System System of Records.

In accordance with 5 U.S.C. 552a(r), DHS has provided a report of this system of records to the Office of Management and Budget and to Congress.

System of RecordsDEPARTMENT OF HOMELAND SECURITY (DHS)/UNITED STATES CITIZENSHIP AND IMMIGRATION SERVICES (USCIS)-007System name:

DHS/USCIS-007 Benefit Information System.

Security classification:

Unclassified, Sensitive, For Official Use Only. The data may be retained on classified networks, but this does not change the nature and character of the data until it is combined with classified information.

System location:

Records are maintained in DHS/USCIS information technology (IT) systems (e.g., Computer Linked Application Information Management System (CLAIMS) 3, CLAIMS 4, Adoptions Case Management System, Case and Activity Management for International Operations) and associated electronic and paper files located at USCIS Headquarters in Washington, DC and in DHS/USCIS service centers and domestic and international field offices. Records are replicated from the operational DHS/USCIS IT systems and maintained on DHS unclassified and classified networks.

Categories of individuals covered by the system:

Categories of individuals covered by this system include (1) persons who have filed, for themselves or on the behalf of others (benefit requestors and beneficiaries), benefit requests for immigration benefits under the Immigration and Nationality Act as amended, and/or who have submitted fee payments or received refunds from such benefit requests; (2) current, former, and potential derivatives of benefit requestors (family members); (3) sponsors (e.g., employers, law enforcement officers, individuals); (4) attorneys and representatives recognized by USCIS and/or accredited by the Board of Immigration Appeals (Representatives); (5) interpreters; (6) individuals who assist in the preparation of the benefit request (Preparers); (7) individuals who make fee payments on behalf of the benefit requestor; and (8) physicians who conduct immigration related medical examinations.

Categories of records in the system:

Information about benefit requestor, beneficiaries, and family members may include:

Authority for maintaining this system is in Sections 103 and 290 of the INA, as amended (8 U.S.C. 1103 and 1360), the regulations issued pursuant thereto; and Section 451 of the Homeland Security Act of 2002 (Pub. L. 107-296).

Purpose(s):

The purpose of this system is to permit USCIS' collection, use, maintenance, dissemination, and storage of paper and electronic benefit request information, including case processing and decisional data not included in the A-File SORN (DHS/USCIS/ICE/CBP-001 Alien File, Index, and National File Tracking System of Records, November 21, 2013, 78 FR 69864). These records assist in the processing of immigrant and nonimmigrant benefit requests from the time when USCIS collects the information from the benefit requestor until the case reaches a final decision in the relevant case management system. This system of records does not cover requests for asylum or refugee status. This system of records notice enables DHS/USCIS to process benefit requests electronically; determine the status of pending benefit requests; account for and control the receipt and disposition of any fees and refunds collected; conduct searches pursuant to Freedom of Information Act (FOIA) and Privacy Act requests; and locate related physical and automated files to support DHS/USCIS responses to inquiries about these records.

DHS/USCIS maintains a replica of some or all of the data in the operating system on DHS unclassified and classified networks to allow for analysis and vetting consistent with the above stated purposes and this published notice.

Routine uses of records maintained in the system, including categories of users and the purposes of such uses:

In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed outside DHS as a routine use pursuant to 5 U.S.C. 552a(b)(3). Even when a valid routine use permits disclosure of information from this system of records to a third party, in some cases such disclosure may not be permissible because of confidentiality laws and policies that limit the sharing of information regarding individuals applying for certain immigration or non-immigration benefits.

Information in this system of records contains information relating to persons who have pending or approved benefit requests for special protected classes and should not be disclosed pursuant to a routine use unless disclosure is otherwise permissible under the confidentiality statutes, regulations, or policies applicable to that information. For example, information relating to persons who have pending or approved benefit requests for protection under the Violence Against Women Act, Seasonal Agricultural Worker or Legalization claims, the Temporary Protected Status of an individual, and information relating to nonimmigrant visas protected under special confidentiality provisions should not be disclosed pursuant to a routine use unless disclosure is otherwise permissible under the confidentiality statutes, regulations, or policies applicable to that information. These confidentiality provisions do not prevent DHS from disclosing information to the U.S. Department of Justice (DOJ) and Offices of the United States Attorney as part of an ongoing criminal or civil investigation.

A. To the DOJ, including Offices of the United States Attorneys, or other federal agency conducting litigation or in proceedings before any court, adjudicative, or administrative body, when it is relevant or necessary to the litigation and one of the following is a party of the litigation or has an interest in such litigation:

1. DHS or any component thereof;

2. Any employee or former employee of DHS in his/her official capacity;

3. Any employee or former employee of DHS in his/her individual capacity when DOJ or DHS has agreed to represent the employee; or

4. The United States or any agency thereof.

B. To a congressional office from the record of an individual in response to an inquiry from that congressional office made at the request of the individual to whom the record pertains.

C. To the National Archives and Records Administration (NARA) or General Services Administration pursuant to records management inspections being conducted under the authority of 44 U.S.C. 2904 and 2906.

D. To an agency or organization for the purpose of performing audit or oversight operations as authorized by law, but only such information as is necessary and relevant to such audit or oversight function.

E. To appropriate agencies, entities, and persons when:

1. DHS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised;

2. DHS has determined that as a result of the suspected or confirmed compromise, there is a risk of identity theft or fraud, harm to economic or property interests, harm to an individual, or harm to the security or integrity of this system or other systems or programs (whether maintained by DHS or another agency or entity) that rely upon the compromised information; and

3. The disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with DHS' efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.

F. To contractors and their agents, grantees, experts, consultants, and others performing or working on a contract, service, grant, cooperative agreement, or other assignment for DHS, when necessary to accomplish an agency function related to this system of records. Individuals provided information under this routine use are subject to the same Privacy Act requirements and limitations on disclosure as are applicable to DHS officers and employees.

G. To an appropriate federal, state, tribal, local, international, or foreign law enforcement agency or other appropriate authority charged with investigating or prosecuting a violation, enforcing, or implementing a law, rule, regulation, or order, when a record, either on its face or in conjunction with other information, indicates a violation or potential violation of law, which includes criminal, civil, or regulatory violations and such disclosure is proper and consistent with the official duties of the person making the disclosure.

H. To clerks and judges of courts exercising naturalization jurisdiction for the purpose of filing applications for naturalization and to enable such courts to determine eligibility for naturalization or grounds for revocation of naturalization.

I. To the Department of State for the purpose of assisting in the processing of benefit requests under the Immigration and Nationality Act, and all other immigration and nationality laws including treaties and reciprocal agreements.

J. To appropriate Federal, State, tribal, and local government law enforcement and regulatory agencies, foreign governments, and international organizations, as well as to other individuals and organizations during the course of an investigation by DHS or the processing of a matter under DHS jurisdiction, or during a proceeding within the purview of the immigration and nationality laws, when DHS deems that such disclosure is necessary to carry out its functions and statutory mandates to elicit information required by DHS to carry out its functions and statutory mandates.

K. To an appropriate Federal, State, local, tribal, foreign, or international agency, if the information is relevant and necessary to a requesting agencies decision concerning the hiring or retention of an individual, or issuance of a security clearance, license, contract, grant, or other benefit, or if the information is relevant and necessary to a DHS decision concerning the hiring or retention of an employee, the issuance of a security clearance, the reporting of an investigation of an employee, the letting of a contract, or the issuance of a license, grant, or other benefit and when such disclosure is appropriate to the proper performance of the official duties of the person making the request.

L. To the Office of Management and Budget in connection with the review of private relief legislation as set forth in OMB Circular No. A-19 at any stage of the legislative coordination and clearance process as set forth in the Circular.

M. To an attorney or representative (as defined in 8 CFR 1.1(j)) who is acting on behalf of an individual covered by this system of records in connection with any proceeding before DHS/USCIS or the Executive Office for Immigration Review.

N. To a federal, state, tribal, or local government agency to assist such agencies in collecting the repayment of loans, fraudulently or erroneously secured benefits, grants, or other debts owed to them or to the United States Government, or to obtain information that may assist USCIS in collecting debts owed to the United States Government.

O. To a foreign government to assist such government in collecting the repayment of loans, fraudulently or erroneously secured benefits, grants, or other debts owed to it, provided that the foreign government in question:

1. Provides sufficient documentation to establish the validity of the stated purpose of its request; and

2. Provides similar information to the United States upon request.

P. To a coroner for purposes of affirmatively identifying a deceased individual (whether or not such individual is deceased as a result of a crime).

Q. Consistent with the requirements of the Immigration and Nationality Act, to the Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC), or to any State or local health authorities, to:

1. Provide proper medical oversight of DHS-designated civil surgeons who perform medical examinations of both arriving foreign nationals and of those requesting status as a lawful permanent resident; and

2. To ensure that all health issues potentially affecting public health and safety in the United States are being or have been, adequately addressed.

R. To a federal, state, or local government agency seeking to verify or ascertain the citizenship or immigration status of any individual within the jurisdiction of the agency for any purpose authorized by law.

S. To the Social Security Administration (SSA) for the purpose of issuing a Social Security number and card to an alien who has made a request for a Social Security number as part of the immigration process and in accordance with any related agreements in effect between the SSA, DHS, and the Department of State entered into pursuant to 20 CFR 422.103(b)(3); 422.103(c); and 422.106(a), or other relevant laws and regulations.

T. To a former employee of DHS, in accordance with applicable regulations, for purposes of responding to an official inquiry by a federal, state, or local government entity or professional licensing authority; or facilitating communications with a former employee that may be necessary for personnel-related or other official purposes when the Department requires information or consultation assistance from the former employee regarding a matter within that persons former area of responsibility.

U. To an individual's prospective or current employer to the extent necessary to determine employment eligibility (for example, pursuant to the Form I-140, Immigrant Petition for Alien Worker).

V. To a federal, state, or local agency, or other appropriate entities or individuals, or through established liaison channels to selected foreign governments, in order to provide intelligence, counterintelligence, or other information for the purposes of intelligence, counterintelligence, or antiterrorism activities authorized by U.S. law, or Executive Order.

W. To approved federal, state, and local government agencies that grant public benefits, licenses, grants, governmental credentials, or any other statutorily authorized purpose when the immigration status of the benefit applicant is legally required and an approved Memorandum of Agreement or Computer Matching Agreement (CMA) is in place between DHS and the entity.

X. To the Department of Labor for enforcement of labor certification violations and violations of U.S. labor laws.

Y. To the news media and the public during the course of naturalization ceremonies administered by USCIS or an Immigration Judge. Pursuant to 8 CFR 337.2 individuals to be naturalized are generally required to appear in a public ceremony, unless an appearance is specifically excused.

Z. To the Department of Treasury to perform initial processing of benefit requests and to accept and resolve payment and any related issues.

AA. To the news media and the public, with the approval of the Chief Privacy Officer in consultation with counsel, when there exists a legitimate public interest in the disclosure of the information, when disclosure is necessary to preserve confidence in the integrity of DHS, or when disclosure is necessary to demonstrate the accountability of DHS officers, employees, or individuals covered by the system, except to the extent the Chief Privacy Officer determines that release of the specific information in the context of a particular case would constitute an unwarranted invasion of personal privacy.

Disclosure to consumer reporting agencies:

Through the ICE Financial Operations—Burlington at DHS, Benefits Information Systems information may be shared with credit reporting agencies. The primary mission of the ICE Financial Operations—Burlington is to collect debts resulting from an individual's participation in DHS benefits programs. USCIS may share Benefits Information System information with the ICE Financial Operations—Burlington regarding fees charged during the various benefit requests processes to ensure collection of debts.

Pursuant to 5 U.S.C. 552a(b)(12), the Department of Treasury Financial Management Service, on behalf of USCIS, may disclose to consumer reporting agencies in accordance with the provision of 15 U.S.C. 1681, et seq. or the Federal Claims Collection Act of 1966 as amended (31 U.S.C. 3701, et seq.). The purpose of this disclosure is to aid in the collection of outstanding debts owed to the Federal Government, typically, to provide an incentive for debtors to repay delinquent Federal Government debts by making these part of their credit records.

Disclosure of records is limited to the individual's name, address, EIN/SSN, and other information necessary to establish the individual's identity; the amount, status, and history of the claim; and the agency or program under which the claim arose. The disclosure will be made only after the procedural requirements of 31 U.S.C. 3711(e) have been followed.

Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system:Storage:

DHS/USCIS stores records in this system electronically in the operational IT systems (such as CLAIMS 3 and CLAIMS 4), including on DHS unclassified and classified networks, or on paper in secure facilities in a locked drawer or behind a locked door. The records may be stored on magnetic disc, tape, within cloud service providers, and digital media.

Retrievability:

Records may be retrieved by any of the data elements listed above or a combination thereof. This may include, but is not limited to, name, date of birth, Alien Number, SSN, USCIS Online Account Number, and Receipt Number.

Safeguards:

DHS/USCIS safeguards records in this system according to applicable rules and policies, including all applicable DHS automated systems security and access policies. DHS/USCIS has imposed strict controls to minimize the risk of compromising the information that is being stored. Access to the computer system containing the records in this system is limited to those individuals who have a need to know the information for the performance of their official duties and who have appropriate clearances or permissions.

Retention and disposal:

DHS/USCIS stores the physical documents (paper forms) and supplemental documentation in the Alien File and processes benefit requests in the respective DHS/USCIS case management system. The A-File records are permanent whether hard copy or electronic. DHS/USCIS transfers the A-Files to the custody of NARA 100 years after the individual's date of birth.

Electronic benefits information is archived and disposed of in accordance with NARA-approved retention schedule for the respective USCIS systems.

• Electronic data pertaining to applications for naturalization will be deleted 15 years after the processing of the benefit being sought is completed. Information in the master file is destroyed 15 years after the last completed action with respect to the application.

• Electronic records pertaining to benefits other than naturalization completed by benefit requestors domestically are destroyed after the data is transferred to the electronic master file and verified. Information in the master file is destroyed 50 years after the last completed action with respect to the benefit.

• Electronic records pertaining to benefits requests other than naturalization and are completed by benefit requestors internationally are destroyed after the data is transferred to the electronic master file and verified. Information in the master file is destroyed 25 years after the last completed action with respect to the benefit.

• Electronic notices and communications associated with a benefit request, to include Approval or Denial letters, Requests for Evidence, Notices of Intent to Deny, Appeal/Motion Responses, etc. are retained for 13 years after the last completed action with respect to the benefit.

• Electronic appointments with USCIS are maintained for 60 days after the date of the appointment.

• Daily reports generated by associated information technology systems are maintained in accordance with the respective retention schedule and then destroyed.

Records replicated on the unclassified and classified networks for analysis and vetting will follow the same retention schedule.

Individuals seeking notification of and access to any record contained in this system of records, or seeking to contest its content, may submit a request in writing to the National Records Center, Freedom of Information Act (FOIA)/Privacy Act (PA) Office, P.O. Box 648010, Lee's Summit, MO 64064-8010. Specific FOIA information can be found at http://www.dhs.gov/foia under “Contacts.” If an individual believes more than one component maintains Privacy Act records concerning him or her, the individual may submit the request to the Chief Privacy Officer and Chief FOIA Officer, Department of Homeland Security, 245 Murray Drive SW., Building 410, STOP-0655, Washington, DC 20528.

When seeking records about yourself from this system of records or any other Departmental system of records, your request must conform with the Privacy Act regulations set forth in 6 CFR part 5. You must first verify your identity, meaning that you must provide your full name, current address, and date and place of birth. You must sign your request, and your signature must either be notarized or submitted under 28 U.S.C. 1746, a law that permits statements to be made under penalty of perjury as a substitute for notarization. While no specific form is required, you may obtain forms for this purpose from the Chief Privacy Officer and Chief FOIA Officer, http://www.dhs.gov/foia or 1-866-431-0486. In addition, you should:

• Explain why you believe the Department would have information on you;

• Identify which component(s) of the Department you believe may have the information about you;

• Specify when you believe the records would have been created; and

• Provide any other information that will help the FOIA staff determine which DHS component agency may have responsive records;

If your request is seeking records pertaining to another living individual, you must include a statement from that individual certifying his/her agreement for you to access his/her records.

Without the above information, the component(s) may not be able to conduct an effective search, and your request may be denied due to lack of specificity or lack of compliance with applicable regulations.

In processing requests for access to information in this system, USCIS will review the records in the operational system and coordinate with DHS to address access to records on the DHS unclassified and classified networks.

Record access procedures:

See “Notification procedure” above.

Contesting record procedures:

See “Notification procedure” above.

Record source categories:

DHS/USCIS obtains records from the benefit requestor, his or her Representative, Physician, Preparer, or Interpreter. DHS/USCIS personnel may input information as they process a case, including information from internal and external sources to verify whether a benefit requestor or family is eligible for the benefit requested. BIS also stores and uses information from the following USCIS, DHS, and other federal agency systems of records:

In accordance with the Privacy Act of 1974, the Department of Homeland Security (DHS) proposes to establish a new Department of Homeland Security system of records titled, “DHS/United States Citizenship and Immigration Services (USCIS)-017 Refugee Case Processing and Security Screening Information” system of records. DHS/USCIS collects, uses, and maintains records on individuals seeking refugee status.

This newly established system will be included in the Department of Homeland Security's inventory of record systems.

DATES:

Submit comments on or before November 18, 2016. This new system will be effective November 18, 2016.

ADDRESSES:

You may submit comments, identified by docket number DHS-2016-0047 by one of the following methods:

Instructions: All submissions received must include the agency name and docket number for this rulemaking. All comments received will be posted without change to http://www.regulations.gov, including any personal information provided.

Docket: For access to the docket to read background documents or comments received, please visit http://www.regulations.gov.

In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, the DHS/USCIS proposes to establish a new DHS system of records titled, “DHS/USCIS-017 Refugee Case Processing and Security Screening Information” system of records.

A refugee is generally defined under U.S. law as a person who is outside his or her country of origin and is unable or unwilling to return because of past persecution or a well-founded fear of future persecution on account of race, religion, nationality, political opinion, or membership in a particular social group. In certain instances, under U.S. law, persons within their countries of nationality or habitual residence may be considered refugees for the purpose of admission to United States. The U.S. Refugee Admissions Program (USRAP) was created by the Executive Branch and authorized by Congress to admit foreign nationals who are outside the United States as refugees. An applicant must first be given access to the USRAP before he or she can be considered for eligibility as a refugee. The USRAP is an interagency partnership involving federal agencies, such as the Department of State (DOS) and DHS, and international and nongovernmental organizations working together, both overseas and domestically, to identify and admit qualified refugees for resettlement into the United States. Within DHS, USCIS has responsibility for adjudicating applications for refugee status and reviewing case decisions, and U.S. Customs and Border Protection (CBP) screens arriving refugees for admission at the port of entry.

Data on refugee applications are entered into the DOS-owned and operated Worldwide Refugee Admissions Processing System (WRAPS), which is an electronic case management system for refugee resettlement that is used by DOS Bureau of Population, Refugees, and Migration (PRM) and its worldwide partners and facilitates the refugee resettlement process. WRAPS contains case information and tracks the processing of refugee applications as they move through the required administrative and adjudicative steps until arrival in the United States.

USCIS is responsible for determining applicants' eligibility for refugee status based on in-person interviews with USCIS adjudicators. Refugee applicants are also subject to numerous biographic and biometric security checks. Refugees are considered for resettlement in the United States if they meet one of the three processing priorities established by DOS:

(1) The Office of the United Nations High Commissioner for Refugees (UNHCR), a U.S. Embassy, or a specially trained non-governmental organization refers them to the United States for resettlement consideration;

(2) Groups of special concern identified by the USRAP; or

(3) Family reunification cases (i.e., spouses, unmarried children under 21, parents of persons lawfully admitted to the United States as refugees or asylees, or persons who are lawful permanent residents or U.S. citizens who previously had refugee or asylum status for designated nationalities).

Generally, refugees must be outside their country of origin or last habitual residence to be eligible for access to the USRAP; however the USRAP has legal authority to process refugees in their home countries in certain locations.

All refugee applicants, derivatives, and certain family members are subject to background security checks. As part of this process, refugee applicants undergo a series of biometric and biographic checks. USCIS may provide enhanced review and screening of certain refugee cases. Through close coordination with the federal law enforcement and intelligence communities, these checks are continually reviewed and enhanced. Additionally, in some instances these checks may involve reviewing social media to identify information on applicants related to national security concerns and/or the refugee eligibility determination.

If the USCIS adjudicator finds that the individual qualifies as a refugee and meets other U.S. admission criteria, the officer will approve or conditionally approve the refugee's application for resettlement and submit it to the Resettlement Support Center (RSC) for further processing. Conditional approvals become final once the results of all background checks have been received and reviewed by USCIS. Upon arrival in the United States, and after admission by a CBP Officer, USCIS creates the A-Files from the refugee travel packet and from documents forwarded from the RSC.

Individuals admitted to the United States as a refugee are required to apply for adjustment of status to that of a lawful permanent resident one year after admission as refugees. Until adjustment of status, persons admitted as refugees possess “refugee status,” unless such status is terminated by USCIS. Employment authorization for refugees admitted to the United States is incidental to refugee status. A refugee admitted to the United Statement may request derivative refugee status for his/her spouse and unmarried children under the age of 21 within two years of admission as a refugee by filing Form I-730, Refugee/Asylee Relative Petition. Refugees who wish to travel abroad may obtain a refugee travel document in order to facilitate their return to the United States. USCIS is also responsible for processing applications for permanent residency, employment authorization, and refugee travel documents, which are processed in the Computer Linked Applications Management System 3 (CLAIMS 3) and Case and Activity Management for International Operations (CAMINO). More information on these systems is available at www.dhs.gov/privacy. Benefit request forms are stored in either the A-File or Receipt File.

USCIS has established the Refugee Case Processing and Security Screening Information system of records to facilitate intake, adjudication, and review of refugee programs. USCIS uses Refugee Case Processing and Security Screening Information to track case status, as well as initiate, facilitate, and track biometric and biographic check screenings and to prevent the approval of any benefit prior to the review and completion of all background checks. Finally, these records are used by USCIS to generate statistical reports to assist with oversight of production and processing goals.

As a matter of policy, the regulations at 8 CFR 208.6 prohibiting disclosure of information contained in or pertaining to an alien's application for asylum, credible fear determination, or reasonable fear determination are applied to an alien's application or status as a refugee. USCIS affords information covered by the DHS/USCIS-017 Refugee Case Processing and Security Screening Information System SORN the confidentiality protections contained in 8 CFR 208.6, which strictly limits the disclosure of information to third parties. Information protected by 8 CFR 208.6 may not be disclosed without the written consent of the applicant, except as permitted by 8 CFR 208.6(c) or at the discretion of the Secretary of Homeland Security or the Attorney General of the United States.

Consistent with DHS's information sharing mission, information covered by the DHS/USCIS-017 Refugee Case Processing and Security Screening Information SORN may be shared with other DHS components that have a need-to-know the information to carry out their national security, law enforcement, immigration, intelligence, or other homeland security functions. In addition, DHS/USCIS may share information with appropriate federal, state, local, tribal, territorial, foreign, or international government agencies consistent with the confidentiality provisions of 8 CFR. 208.6 and with the routine uses set forth in this system of records notice.

This new system will be included in DHS's inventory of record systems.

II. Privacy Act

The Privacy Act embodies fair information practice principles in a statutory framework governing the means by which federal government agencies collect, maintain, use, and disseminate individuals' records. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to the individual. In the Privacy Act, an individual is defined to encompass U.S. citizens and lawful permanent residents. As a matter of policy, DHS extends administrative Privacy Act protections to all individuals when systems of records maintain information on U.S. citizens, lawful permanent residents, and visitors.

Below is the description of the DHS/USCIS-017 Refugee Case Processing and Security Screening Information System of Records.

In accordance with 5 U.S.C. 552a(r), DHS has provided a report of this system of records to the Office of Management and Budget and to Congress.

Unclassified, Sensitive, For Official Use Only. The data may be retained on classified networks, but this does not change the nature and character of the data until it is combined with classified information.

System location:

Records are maintained in DHS/USCIS information technology (IT) systems and associated electronic and paper files located at USCIS Headquarters in Washington, DC and in DHS/USCIS service centers and domestic and international field offices to support USCIS Refugee, Asylum, and International Operations (RAIO) Refugee Affairs Division (RAD). The DHS/USCIS IT systems, as well as DOS IT systems that support the Refugee Case Processing and Security Screening Information include: The DOS WRAPS, USCIS CAMINO, and CLAIMS 3. Refugee application data and biographic check results for the principal applicant, derivatives, and other family members are processed in DOS WRAPS and USCIS CAMINO. Biometric check results for the refugee applicant and derivatives are stored in the USCIS Customer Profile Management System (CPMS). Applications for the adjustment of status, refugee travel documents, and follow-to-join benefit petitions Form I-730, are processed in USCIS CAMINO and CLAIMS 3. Records are replicated from the operational DHS/USCIS IT systems and maintained on DHS unclassified and classified networks.

Categories of individuals covered by the system:

Categories of individuals covered by this system include: (1) Individuals who have applied for admission to the United States under the USRAPS; (2) spouses (current and former) and children of a principal refugee applicant included in the refugee application; (3) principal refugee applicant's parents and relatives in the United States; (4) other individuals listed as part of the family tree and including points of contact in the United States and other individuals with whom the applicant associates; (5) individuals who have petitioned for follow-to-join (derivative) refugee or asylum status for their spouse and unmarried children under the age of 21 on Form I-730 Refugee/Asylee Relative Petition; (6) persons who complete refugee applications on behalf of the refugee applicant (e.g., form preparers, interpreters); and (7) individuals associated with partner organizations such as Resettlement Support Centers and the United Nations High Commissioner for Refugees.

Categories of records in the system:

Information about benefit requestor and derivatives may include:

• Full name;

• Alias(es);

• Physical and mailing addresses;

• Date of birth;

• Place of birth;

• Gender;

• Ethnicity or tribal group;

• Religion;

• Present Citizenship or Nationality;

• Alien Number (A-Number);

• Resettlement Support Center Case Number;

• Receipt Number;

• USCIS Online Account Number;

• Social Security number (SSN), if any;

• Relationship to benefit requestor (i.e., children under the age of 21 and spouse);

• Employment authorization eligibility and application history;

• Records regarding organization membership or affiliation;

• Supporting documentation as necessary (e.g., birth, marriage, divorce certificates; licenses; academic diplomas; academic transcripts; appeals or motions to reopen or reconsider decisions; explanatory statements; and unsolicited information submitted voluntarily by the applicant or family members in support of a benefit request);

• Reports of investigations or derogatory information obtained from DHS and other federal systems;

• Refugee interview notes and assessments;

• Information regarding the status of Department of Justice (DOJ), Executive Office of Immigration Review (EOIR) proceedings, if applicable; and

• Case processing information such as date applications were filed or received by USCIS; application/petition status, location of record, other control number when applicable, and fee receipt data.

Information about the benefit requestor's parents and relatives in the United States and other individuals listed as part of the family tree and including points of contact in the United States and other individuals with whom the applicant associates:

• Name;

• Date of Birth;

• Relationship to the benefit requestor;

• Country of Birth;

• Address; and

• Background check results.

Information about Registrants, Preparers, and Interpreters may include:

• Full name;

• Organization;

• Business State ID number;

• Employer Tax Identification Number;

• Physical and mailing addresses:

• Email address;

• Phone and fax numbers;

• Relationship to applicant; and

• Signature.

Information about Accredited Representatives and Attorneys includes:

• Name;

• Law Firm/Recognized Organization;

• Physical and mailing addresses:

• Phone and fax numbers;

• Email address;

• Attorney Bar Card Number or equivalent;

• Bar membership;

• Accreditation date;

• Board of Immigration Appeals Representative Accreditation;

• Expiration date;

• Law Practice Restriction Explanation; and

• Signature.

Authority for maintenance of the system:

Authority for maintaining this system is in Section 207 of the Immigration and Nationality Act (INA), as amended.

Purpose(s):

The purpose of this system is to collect, use, maintain, disseminate, and store refugee information, including the administration and adjudication of the review of refugee applications and follow-to-join applications for those who are seeking consideration for refugee resettlement, as well as applications for permanent residency, employment authorization, and travel abroad.

Routine uses of records maintained in the system, including categories of users and the purposes of such uses:

In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed outside DHS as a routine use pursuant to 5 U.S.C. 552a(b)(3). Even when a valid routine use permits disclosure of information from this system of records to a third party, in some cases such disclosure may not be permissible because of confidentiality laws and policies that limit the sharing of information regarding individuals applying for refugee status.

Information in this system of records contains information relating to persons who have pending or approved refugee applications or pending or approved follow-to-join petitions should not be disclosed pursuant to a routine use unless disclosure is otherwise permissible under 8 CFR 208.6. These confidentiality provisions do not prevent DHS from disclosing information to the DOJ and Offices of the United States Attorneys as part of an ongoing criminal or civil investigation. These provisions permit disclosure to courts under certain circumstances as well, as provided under 8 CFR 208.6(c)(2). Subject to these restrictions:

A. To the DOJ, including Offices of the United States Attorneys, or other federal agency conducting litigation or in proceedings before any court, adjudicative, or administrative body, when it is relevant or necessary to the litigation and one of the following is a party of the litigation or has an interest in such litigation:

1. DHS or any component thereof;

2. Any employee or former employee of DHS in his/her official capacity;

3. Any employee or former employee of DHS in his/her individual capacity when DOJ or DHS has agreed to represent the employee; or

4. The United States or any agency thereof.

B. To a congressional office from the record of an individual in response to an inquiry from that congressional office made at the request of the individual to whom the record pertains.

C. To the National Archives and Records Administration (NARA) or other Federal Government agencies pursuant to records management inspections being conducted under the authority of 44 U.S.C. 2904 and 2906.

D. To an agency or organization for the purpose of performing audit or oversight operations as authorized by law, but only such information as is necessary and relevant to such audit or oversight function.

E. To appropriate agencies, entities, and persons when:

1. DHS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised;

2. DHS has determined that as a result of the suspected or confirmed compromise, there is a risk of identity theft or fraud, harm to economic or property interests, harm to an individual, or harm to the security or integrity of this system or other systems or programs (whether maintained by DHS or another agency or entity) that rely upon the compromised information; and

3. The disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with DHS's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.

F. To contractors and their agents, grantees, experts, consultants, and others performing or working on a contract, service, grant, cooperative agreement, or other assignment for DHS, when necessary to accomplish an agency function related to this system of records. Individuals provided information under this routine use are subject to the same Privacy Act requirements and limitations on disclosure as are applicable to DHS officers and employees.

G. To an appropriate federal, state, tribal, local, international, or foreign law enforcement agency or other appropriate authority charged with investigating or prosecuting a violation or enforcing or implementing a law, rule, regulation, or order, when a record, either on its face or in conjunction with other information, indicates a violation or potential violation of law, which includes criminal, civil, or regulatory violations and such disclosure is proper and consistent with the official duties of the person making the disclosure.

H. To DOS, their contractors, agents, grantees, experts, consultants, or others performing or working on a contract, service, grant, cooperative agreement, or other assignment for DOS (e.g., RSC, International Organization for Migration), when necessary to accomplish refugee case processing.

I. To federal and foreign government intelligence or counterterrorism agencies or components when DHS becomes aware of an indication of a threat or potential threat to national or international security, or when such use is to assist in anti-terrorism efforts and disclosure is appropriate to the proper performance of the official duties of the person making the disclosure.

J. To requesting foreign governments under appropriate information sharing agreements and there is a legitimate need to share information for law enforcement or national security purposes under 8 CFR 208.6.

Disclosure to consumer reporting agencies:

None.

Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system:Storage:

DHS/USCIS stores records in this system electronically or on paper in secure facilities in a locked drawer behind a locked door. The records may be stored on magnetic disc, tape, and digital media.

DHS/USCIS safeguards records in this system according to applicable rules and policies, including all applicable DHS automated systems security and access policies. DHS/USCIS has imposed strict controls to minimize the risk of compromising the information that is being stored. Access to the computer system containing the records in this system is limited to those individuals who have a need to know the information for the performance of their official duties and who have appropriate clearances or permissions.

Retention and disposal:

DHS/USCIS stores the physical documentation in the Alien File, and maintains refugee case processing and security screening information and follow-to-join applications in the respective case management systems. The A-File records are permanent whether hard copy or electronic. USCIS transfers the A-Files to the custody of NARA 100 years after the individual's date of birth.

CAMINO Master File automated records are maintained for 25 years after the case is closed and then destroyed.

CLAIMS 3 records are destroyed after the data is transferred to the electronic master file and verified. Information in the master file is destroyed 15 years after the last completed action with respect to the benefit. USCIS is proposing to update the CLAIMS 3 Retention Schedule to destroy records 50 years after the last completed action. This retention schedule allows USCIS to address any follow-up inquiries or requests related to the application, including inquiries related to law enforcement, public safety, and national security, and to respond to Freedom of Information Act/Privacy Act (FOIA/PA) matters.

The biometric check data is retained in CPMS, which is governed by a DHS-wide retention schedule. The records in CPMS are retained for 100 years from the individual's data of birth in accordance with the NARA Disposition Authority Number DAA-0563-2013-0001-0005.

For refugee follow-to-join records, the DHS system manager is the Chief, International Operations Division, Refugee, Asylum, and International Operations Directorate, U.S. Citizenship and Immigration Services, Department of Homeland Security, 111 Massachusetts Avenue NW., Washington, DC 20529.

For refugee records relating to adjustment of status and travel, the DHS system manger is the Associate Director, Service Center Operations Directorate, U.S. Citizenship and Immigration Services, Department of Homeland Security, 111 Massachusetts Avenue NW., Washington, DC 20529.

Notification procedure:

Individuals seeking notification of and access to any record contained in this system of records, or seeking to contest its content, may submit a request in writing to the National Records Center (NRC) FOIA/PA Office, P.O. Box 648010, Lee's Summit, MO, 64064-8010, whose contact information can be found at http://www.dhs.gov/foia under “Contacts.” If an individual believes more than one component maintains Privacy Act records concerning him or her, the individual may submit the request to the Chief Privacy Officer and Chief Freedom of Information Act Officer, Department of Homeland Security, 245 Murray Drive SW., Building 410, STOP-0655, Washington, DC 20528.

When seeking records about yourself from this system of records or any other Departmental system of records, your request must conform with the Privacy Act regulations set forth in 6 CFR part 5. You must first verify your identity, meaning that you must provide your full name, current address, and date and place of birth. You must sign your request, and your signature must either be notarized or submitted under 28 U.S.C. 1746, a law that permits statements to be made under penalty of perjury as a substitute for notarization. While no specific form is required, you may obtain forms for this purpose from the Chief Privacy Officer and Chief Freedom of Information Act Officer, http://www.dhs.gov/foia or 1-866-431-0486. In addition, you should:

• Explain why you believe the Department would have information on you;

• Identify which component(s) of the Department you believe may have the information about you;

• Specify when you believe the records would have been created; and

• Provide any other information that will help the FOIA staff determine which DHS component agency may have responsive records;

If your request is seeking records pertaining to another living individual, you must include a statement from that individual certifying his/her agreement for you to access his/her records.

Without the above information, the component(s) may not be able to conduct an effective search, and your request may be denied due to lack of specificity or lack of compliance with applicable regulations.

Record access procedures:

See “Notification procedure” above.

Contesting record procedures:

See “Notification procedure” above.

Record source categories:

DHS/USCIS obtains records from the applicant, and his or her accredited representative, preparer, or interpreter. Other information sources include family members, federal databases for security screening checks, RSCs, the DOS Refugee Processing Center, resettlement agencies, international organizations, and local sources at overseas sites. DHS/USCIS personnel may input information as they process a case, including information from internal and external sources to verify whether a benefit requestor or family is eligible for the refugee benefit requested. Refugee Case Process and Security Screening also stores and uses information from the following USCIS, DHS, and other federal agency systems of records:

In accordance with the Privacy Act of 1974, the Department of Homeland Security (DHS) proposes to update, rename, and reissue a current DHS system of records titled, “DHS//U.S. Immigration and Customs Enforcement (ICE)-011 Immigration and Enforcement Operational Records (ENFORCE)” system of records. DHS/ICE collects, uses, and maintains ENFORCE to support the identification, apprehension, and removal of individuals unlawfully entering or present in the United States in violation of the Immigration and Nationality Act, including fugitive aliens. DHS/ICE also uses ENFORCE to support the identification and arrest of individuals (both citizens and non-citizens) who commit violations of federal criminal laws enforced by DHS. This system of records is being created from a previously issued system of records, DHS/ICE 011-Immigration and Enforcement Operational Records (ENFORCE). See 80 FR 24,269 (Apr. 30, 2015).

DHS/ICE is updating this system of records to: Change the system of records name to “DHS/ICE-011 Criminal Arrest Records and Immigration Enforcement Records (CARIER)” System of Records; update and reorganize the categories of individuals for clarity; expand the categories of records to include recordings of detainee telephone calls and information about these calls, as well as information related to detainees' accounts for telephone or commissary services in a detention facility; update the system manager; clarify system location; and add twenty-five routine uses and modify twenty routine uses to describe how the Department of Homeland Security may share information from this system. Additionally, this notice includes non-substantive changes to simplify the formatting and text of the previously published notice.

This updated system will be included in the Department of Homeland Security's inventory of record systems.

DATES:

Submit comments on or before November 18, 2016. This updated system will be effective November 18, 2016.

ADDRESSES:

You may submit comments, identified by docket number DHS-2016-0073 by one of the following methods:

Instructions: All submissions received must include the agency name and docket number for this rulemaking. All comments received will be posted without change to http://www.regulations.gov, including any personal information provided.

Docket: For access to the docket to read background documents or comments received, please visit http://www.regulations.gov.

In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, DHS/ICE is updating, renaming, and reissuing a DHS system of records now titled, “DHS/Immigration and Enforcement (ICE)-011 Criminal Arrest Records and Immigration Enforcement Records (CARIER) System of Records.”

The DHS/ICE update to CARIER includes several changes. First, the system of records is being renamed to better align it with the purpose of the system. This system of records covers records documenting ICE's criminal arrests, and also those documenting most of ICE's immigration enforcement actions, such as the issuance of immigration detainers; the arrests, charging, detention, and removal of aliens for administrative immigration violations; the search for and apprehension of fugitive aliens; and ICE decisions concerning the grant or denial of parole to aliens. This system of records is being created from a previously issued system of records named, DHS/ICE 011-Immigration and Enforcement Operational Records (ENFORCE), 80 FR 24,269 (Apr. 30, 2015).

Second, this update seeks to clarify the types of individuals whose information is contained in this system of records. Some items in the category of individuals section have been reorganized and edited to more clearly identify the individuals whose records may be present in this system of records.

Third, the categories of records section has been expanded to provide a more detailed and complete list of the types of information contained in the system of records. The new categories of records added to the system of records are domestic and foreign criminal history information; information related to detainees' accounts for telephone or commissary services in a detention facility; and video recordings of detainees. The CARIER system of records also contains detainee voiceprints used to verify identity when a detainee is released under an alternative to detention program, as well as the actual audio recordings of detainee “check-in” telephone calls. Additionally, the CARIER system of records contains recordings of detainee telephone calls made from a detention facility and information about these calls such as the date, time, duration, and telephone number called (Note: Information for protected telephone calls, such as calls with an attorney, is not recorded).

Fourth, the system location and security classification have been updated to indicate that certain records may be replicated from ICE's Enforcement Integrated Database (EID) and stored on both DHS unclassified and classified networks to allow for analysis and vetting consistent with existing DHS/ICE authorities and purposes and this published notice.

Fifth, the title of the system manager has been updated.

Finally, DHS is proposing to add new routine uses that would allow ICE to share information from the CARIER system of records with the specified recipients for the specified purpose. DHS is also proposing to delete several routine uses and modify several others to clarify their meaning and/or to expand or limit the scope of the information shared. Several of the routine uses being added to or updated in the CARIER SORN are the same routine uses included in the Department of Homeland Security/U.S. Customs and Immigration Services (USCIS)/ICE/Customs and Border Protection (CBP)-001 Alien File, Index, and National File Tracking (A-File) SORN. 78 FR. 69,864, (Nov. 21, 2013). Although both SORNs support the immigration enforcement mission, they often contain different information about aliens that may need to be shared. Therefore, identical or similar routine uses may be needed in both SORNs to ensure that immigration information can be shared as needed for law enforcement and other authorized purposes.

Below is a summary of the new routine uses and their corresponding letter:

(H) To prospective claimants and their attorneys for the purpose of negotiating the settlement of an actual or prospective claim against DHS or its current or former employees, in advance of the initiation of formal litigation or proceedings;

(J) To federal, state, local, tribal, or territorial government agencies, or other entities or individuals, or through established liaison channels to selected foreign governments, in order to provide intelligence, counterintelligence, or other information for the purposes of national security, intelligence, counterintelligence, or antiterrorism activities authorized by U.S. law, E.O., or other applicable national security directive;

(K) To federal and foreign government intelligence or counterterrorism agencies or components when DHS becomes aware of an indication of a threat or potential threat to national or international security, or when such disclosure is to support the conduct of national intelligence and security investigations or to assist in anti-terrorism efforts;

(P) To disclose information to the U.S. Department of Justice (DOJ) Executive Office of Immigration Review (EOIR) and to the Board of Immigration Appeals (the entities that adjudicate immigration cases), to the extent necessary to carry out their authorized duties pertaining to the adjudication of matters arising under the INA;

(DD) To DOJ and other law enforcement or custodial agencies to facilitate payments and reporting under the State Criminal Alien Assistance Program or similar programs;

(EE) To any law enforcement agency or custodial agency (such as a jail or prison) to serve that agency with notice of an immigration detainer, or to update or remove a previously issued immigration detainer, for an individual believed to be in that agency's custody;

(MM) To courts, magistrates, administrative tribunals, opposing counsel, parties, and witnesses, in the course of immigration, civil, or criminal proceedings (including discovery, presentation of evidence, and settlement negotiations), and when DHS determines that use of such records is relevant and necessary to the litigation before a court or adjudicative body when any of the following is a party to or have an interest in the litigation:

1. DHS or any component thereof;

2. Any employee of DHS in his/her official capacity;

3. Any employee of DHS in his/her individual capacity when DOJ or DHS has agreed to represent the employee; or

4. The United States, when DHS determines that litigation is likely to affect DHS or any of its components.

(NN) To federal, state, local, tribal, territorial, international, or foreign government agencies or entities for the purpose of consulting with that agency or entity:

1. To assist in making a determination regarding redress for an individual in connection with the operations of a DHS component or program;

2. To verify the identity of an individual seeking redress in connection with the operations of a DHS component or program; or

3. To verify the accuracy of information submitted by an individual who has requested such redress on behalf of another individual.

(OO) To federal, state, local, tribal, territorial, or foreign governmental agencies; multilateral governmental organizations; or other public health entities, for the purposes of protecting the vital interests of a data subject or other persons, including to assist such agencies or organizations during an epidemiological investigation, in facilitating continuity of care, in preventing exposure to or transmission of a communicable or quarantinable disease of public health significance, or to combat other significant public health threats.

(PP) To foreign governments for the purpose of providing information about their citizens or permanent residents, or family members thereof, during local or national disasters or health emergencies;

(QQ) To a coroner for purposes of affirmatively identifying a deceased individual (whether or not such individual is deceased as a result of a crime) or cause of death;

(RR) To a former employee of DHS for purposes of responding to an official inquiry by federal, state, local, tribal, or territorial government agencies or professional licensing authorities; or facilitating communications with a former employee that may be relevant and necessary for personnel-related or other official purposes, when DHS requires information or consultation assistance from the former employee regarding a matter within that person's former area of responsibility;

(SS) To federal, state, local, tribal, territorial, foreign, or international agencies, if the information is relevant and necessary to a requesting agency's decision concerning the hiring or retention of an individual, or the issuance, grant, renewal, suspension or revocation of a security clearance, license, contract, grant, or other benefit; or if the information is relevant and necessary to a DHS decision concerning the hiring or retention of an employee, the issuance of a security clearance, the reporting of an investigation of an employee, the letting of a contract, or the issuance of a license, grant or other benefit;

(TT) To a public or professional licensing organization when such information indicates, either by itself or in combination with other information, a violation or potential violation of professional standards, or reflects on the moral, educational, or professional qualifications of licensed professionals or who those seeking to become licensed professionals;

(UU) To an attorney or representative (as defined in 8 CFR 1.2, 202.1, 1001.1(f), or 1202.12) who is acting on behalf of an individual covered by this system of records in connection with any proceeding before U.S. Citizenship and Immigration Services (USCIS), ICE, U.S. Customs and Border Protection (CBP), or the EOIR, as required by law or as deemed necessary in the discretion of the Department;

(VV) To members of the public, with regard to disclosure of limited detainee biographical information for the purpose of facilitating the deposit of monies into detainees' accounts for telephone or commissary services in a detention facility;

(WW) To federal, state, local, tribal, or territorial government agencies seeking to verify or ascertain the citizenship or immigration status of any individual within the jurisdiction of the agency for any purpose authorized by law;

(XX) To DOJ or other federal agency conducting litigation or in proceedings before any court, adjudicative or administrative body, when necessary to assist in the development of such agency's legal and/or policy position;

(YY) To federal, state, local, tribal, and territorial courts or government agencies involved in criminal investigation or prosecution, pre-trial, sentencing, parole, probation, bail bonds, or any other aspect of the criminal justice process, and to defense counsel representing an individual in a domestic criminal proceeding, in order to ensure the integrity and efficiency of the criminal justice system by informing these recipients of the existence of an immigration detainer or the individual's status in removal proceedings, including removal or custodial status/location. Disclosure of the individual's Alien Registration Number (A-Number) and country of birth is also authorized to facilitate these recipients' use of the ICE Online Detainee Locator System for the purposes listed above;

(ZZ) To a foreign government to notify it concerning its citizens or residents who are incapacitated, an unaccompanied minor, or deceased;

(AAA) To family members, guardians, committees, friends, or other agents identified by law or regulation to receive notification, decisions, and other papers as provided in 8 CFR 103.8 from DHS or EOIR following verification of a familial or agency relationship with an alien when DHS is aware of indicia of incompetency or when an alien has been determined to be mentally incompetent by an immigration judge;

(BBB) To an organization or person in either the public or private sector, either foreign or domestic, when there is a reason to believe that the recipient is or could become the target of a particular terrorist activity or conspiracy, or when the information is relevant to the protection of life, property, or other vital interests of a person.

(CCC) To clerks and judges of courts exercising naturalization jurisdiction for the purpose of granting or revoking naturalization.

(DDD) To federal, state, local, tribal, territorial, foreign, or international agencies, after discovery of such information, if DHS determines: (1) The information is relevant and necessary to that agency's decision concerning the hiring or retention of an individual, or issuance of a security clearance, license, contract, grant, or other benefit; and (2) Failure to disclose the information is likely to create a substantial risk to government facilities, equipment or personnel; sensitive information; critical infrastructure; or public safety.

Below is a summary of the routine uses that are proposed to be modified or deleted, and their corresponding letter:

(A) Expanded scope to include sharing with the Offices of the United States Attorneys. Also removed sharing with a court, magistrate, administrative tribunal, opposing counsel, parties, and witnesses because routine use LL now permits sharing with these recipients.

(C) Updated to note that records will be provided specifically to the General Services Administration rather than to other Federal Government agencies.

(D) Updated to clarify that records will not be given to individuals, but to agencies or organizations performing the audit.

(E) Updated to add the risk of identity theft or fraud, and harm to economic or property interests as additional risks that DHS may determine may be a result of the suspected or confirmed compromise.

Routine use H in the previous version of the SORN, which authorized disclosure during court proceedings, has been removed and replaced by new routine use MM. The new routine use contains improved wording that is clearer about when disclosures may be made under these circumstances.

(I) Updated to enable DHS to share information when it deems that such disclosure is necessary to carry out its functions and statutory mandates.

(J) Former routine uses J and K have been removed and the sharing they permitted is now combined into one routine use that authorizes disclosure for the purposes of national security, intelligence, counterintelligence, or antiterrorism activities.

Routine use L in the previous version of the SORN has been removed and replaced by a new routine use K permitting sharing with federal and foreign government intelligence or counterterrorism agencies or components in support of national intelligence and security investigations or to assist in anti-terrorism efforts.

(N) Updated to clarify that in disclosing custodial location to family members, attorneys, and other agents acting on the behalf of an alien, the agency may also disclose if the alien was released from ICE custody and/or transferred to the custody of another agency. This authority was implied but not expressly stated in the previous version of routine use N. Also modified to clarify that disclosure is authorized to attorneys representing the alien in any legal proceeding, not only immigration proceedings.

(O) Updated to clarify that information can be shared for other purposes or activities within the scope of the EOIR contract.

(R) (previously routine use Q) Expanded scope to include sharing with domestic courts and to clarify agencies collecting the repayment of loans, or fraudulently or erroneously secured benefits.

(V) (previously routine use U) Expanded scope to include prosecutions and/or other law enforcement actions.

(W) (previously routine use V) Expanded scope to include sharing with federal, state, local, tribal, or territorial law enforcement or correctional agencies concerning individuals in ICE custody that are to be transferred to such agency's custody, in order to coordinate the transportation, custody, and care of the individuals.

(X) (previously routine use W) Expanded scope to include sharing in order to arrange other social services.

(Y) (previously routine use X) Updated to replace ICE with DHS.

(BB) (previously routine use CC) Expanded the sharing of custodial information to witnesses and individuals with a legal responsibility to act on behalf of or acting at the request of a victim or witness, as well as external victim notification systems.

(CC) (previously routine use Y) Scope is narrowed to exclude sharing in order to place an immigration detainer on an individual. Sharing in order to place a detainer is now covered by routine use DD. Additionally, this routine use previously was used when ICE was transferring an individual to another agency. It has been expanded to allow sharing during the course of transfer of custody of an individual either to or from ICE's custody.

(HH) (previously routine use BB) Expanded scope to include sharing with the attorney or guardian ad litem of an individual's child for purposes of allowing the attorney/guardian to identify the location or status of the individual.

(KK) (previously routine use FF) Expanded scope to include sharing with territorial government agencies or entities or multinational governmental agencies. It also expands the purposes of the sharing to developing and implementing new software or technology when the purpose of the software or technology is related to this system of records.

(LL) (previously routine use GG) Former routine use GG has been removed and the sharing it permitted is now contained in two new routine uses to improve clarity: Routine use LL permitting the disclosure of information via the ICE Online Detainee Locator System or any successor system, and routine use VV permitting the disclosure of information to facilitate the deposit of monies into detainees' accounts for telephone or commissary services in a detention facility.

Finally, there have been changes regarding the retention period for some records. Retention periods have been added for records concerning paroled aliens and fugitive aliens maintained in certain ICE information systems. Also, the fingerprints and photographs collected using the booking application EID Arrest Guide for Law Enforcement (EAGLE), previously known as Mobile IDENT, originally were stored for up to seven (7) days in the cache of an encrypted Government laptop or other IT device. Now they are stored for up to fifty (50) days.

Consistent with DHS's information sharing mission, information stored in the DHS/ICE-011 Criminal Arrest Records and Immigration Enforcement Records may be shared with other DHS Components that have a need to know the information to carry out their national security, law enforcement, immigration, intelligence, or other homeland security functions. In addition, DHS/ICE may share information with appropriate federal, state, local, tribal, territorial, foreign, or international government agencies consistent with the routine uses set forth in this system of records notice.

This updated system will be included in DHS's inventory of record systems.

II. Privacy Act

The Privacy Act embodies fair information principles in a statutory framework governing the means by which Federal Government agencies collect, maintain, use, and disseminate individuals' records. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to the individual. In the Privacy Act, an individual is defined to encompass U.S. citizens and lawful permanent residents. As a matter of policy, DHS extends administrative Privacy Act protections to all individuals when systems of records maintain information on U.S. citizens, lawful permanent residents, and visitors.

Below is the description of the DHS/ICE-011 Criminal Arrest Records and Immigration Enforcement Records (CARIER) System of Records.

In accordance with 5 U.S.C. 552a(r), DHS has provided a report of this system of records to the Office of Management and Budget and to Congress.

Unclassified; Controlled Unclassified Information (CUI). The data may be retained on the classified networks, but this does not change the nature and character of the data until it is combined with classified information.

System location:

Records are maintained at DHS/ICE information technology (IT) systems (e.g., the EID and the various ICE applications associated with it, Parole Case Tracking System (PCTS), Online Detainee Locator System (ODLS), Electronic Travel Document (eTD) System, the contractor-owned IT system supporting ICE's Alternatives to Detention (ATD) program) and associated electronic and paper files located at ICE Headquarters in Washington, DC, ICE field and attaché offices, contractor offices, and detention facilities operated by or on behalf of ICE, or that otherwise house individuals arrested or detained by ICE. Records are replicated from the operational DHS/ICE IT systems and maintained on DHS unclassified and classified networks used for analysis and vetting.

Categories of individuals covered by the system:

Categories of individuals covered by this system include (1) individuals arrested, detained, or removed from the United States for criminal or administrative violations of the Immigration and Nationality Act, or individuals issued a Notice to Appear in immigration court; (2) individuals who are the subject of an immigration detainer issued to another law enforcement or custodial agency; (3) individuals arrested by ICE for violations of criminal laws enforced by ICE or DHS; (4) individuals who fail to leave the United States after receiving a final order of removal, deportation, or exclusion, or who fail to report to ICE for removal after receiving notice to do so (fugitive aliens); (5) individuals who illegally re-enter the United States after departing pursuant to an order of voluntary departure or being removed from the United States (illegal re-entrants); (6) individuals who request to be removed at their own expense or are eligible for voluntary removal from the United States pursuant to sec. 250 of the Immigration and Nationality Act; (7) individuals who are granted parole into the United States under sec. 212(d)(5) of the Immigration and Nationality Act (parolees); (8) attorneys or representatives who represent individuals listed in the categories above; (9) other individuals whose information may be collected or obtained during the course of an immigration enforcement or criminal matter, such as witnesses, associates, and relatives; (10) persons who post or arrange bond for the release of an individual from ICE detention, or receive custodial property of a detained alien; and (11) prisoners of the U.S. Marshals Service held in ICE detention facilities.

• Biometric (i.e., fingerprints, voiceprints, iris images, photographs, and DNA samples). DNA samples required by DOJ regulation (see 28 CFR part 28) are collected and sent to the FBI. DNA samples are not retained or analyzed by DHS; and

• Information pertaining to ICE's collection of DNA samples, limited to the date and time of a successful collection and confirmation from the FBI that the sample was able to be sequenced. ICE does not receive or maintain the results of the FBI's DNA analysis (i.e., DNA sequences).

Case-related data:

• Case number;

• Record number;

• Case category;

• Charges brought and disposition;

• Case agent;

• Data initiated and completed; and

• Other data describing an event involving alleged violations of criminal or immigration law (i.e., location; date; time; type of criminal or immigration law violations alleged; type of property involved; use of violence, weapons, or assault against DHS personnel or third parties; attempted escape; and other related information).

Information presented to or collected by ICE during immigration and law enforcement proceedings or activities:

• Date of birth;

• Place of birth;

• Marital status;

• Education history;

• Employment history;

• Travel history; and

• Other information derived from affidavits, certificates, manifests, and other documents. This data typically pertains to subjects, relatives, associates, and witnesses.

Detention data on aliens:

• Immigration detainers issued;

• Transportation information;

• Detention-related identification numbers;

• Detention facility;

• Security, risk, and custody classification;

• Custody recommendation;

• Flight risk indication;

• Book-in/book-out date and time;

• Mandatory detention and criminal flags;

• Aggravated felon status;

• Other alerts;

• Information about an alien's release from custody on bond, recognizance, or supervision;

• Information related to prosecutorial discretion determinations;

• Property inventory and receipt;

• Information related to disciplinary issues or grievances;

• Documents and video recordings related to alleged misconduct and other incidents involving detainees; and

• Other detention-related information (e.g., documentation of an allegation of sexual abuse or assault, documentation of strip and body cavity searches, documentation of reasons for segregation or other housing placement, documentation of participation in the orientation process).

Detention data for U.S. Marshals Service prisoners:

• Full Name;

• Date of birth;

• Country of birth;

• Identification numbers (e.g., detainee, FBI, state);

• Book-in/book-out date and time; and

• Security classification.

Limited health information relevant to an individual's placement in an ICE detention facility or transportation requirements:

• Medical alerts or general information on physical disabilities or other special needs or vulnerabilities to facilitate placement in a facility or bed that best accommodates these needs. Medical records about individuals in ICE custody (i.e., records relating to the diagnosis or treatment of individuals) are maintained in DHS/ICE—013 Alien Medical Records System of Records.

Progress, status, and final result of removal, prosecution, and other DHS processes and related appeals:

• Information relating to criminal convictions;

• Incarceration;

• Travel documents; and

• Other information pertaining to the actual removal of aliens from the United States.

Contact, biographical, and identifying data about Relatives, Attorneys or Representatives, Associates or Witnesses of an alien in proceedings initiated or conducted by DHS may include:

Data concerning personnel of other agencies that arrested, or assisted or participated in the arrest or investigation of, or are maintaining custody of an individual whose arrest record is contained in this system of records may include:

Data about persons who post or arrange an immigration bond for the release of an individual from ICE custody, or receive custodial property of an individual in ICE custody may include:

• Full Name;

• Address;

• Phone numbers;

• SSN; and

• Other information.

Recordings of detainee telephone calls when responding as part of an alternative to detention program or of detainee calls made in detention facilities. Information about these calls may include:

• Date;

• Time;

• Duration; and

• Phone number called. (Note: Protected telephone calls, such as calls with an attorney, are not recorded and information about protected telephone calls is not retained.)

Information related to detainees' accounts for telephone or commissary services in a detention facility.

Authority for maintenance of the system:

Authority for maintain this system is in 8 U.S.C. 1103, 1225, 1226, 1324, 1357, 1360, and 1365(a)(b); Title 18, United States Code, Chapters 27, 77, 85, 95, 109A, 110, 113, and 117; Title 31, United States Code, Chapter 53, Subchapter II; Title 50 Appendix, United States Code; The Tariff Act of 1930; Justice for All Act of 2004 (Pub. L. 108-405); DNA Fingerprint Act of 2005 (Pub. L. 109-162); Adam Walsh Child Protection and Safety Act of 2006 (Pub. L. 109-248); and 28 CFR part 28, “DNA-Sample Collection and Biological Evidence Preservation in the Federal Jurisdiction;” DHS Delegation Number 7030.2, Delegation of Authority to the Assistant Secretary for the Bureau of Immigration and Customs Enforcement and the Reorganization Plan Modification for the Department of Homeland Security (January 30, 2003).

Purpose(s):

The purposes of this system are:

1. To support the identification, arrest, charging, detention, and removal of individuals unlawfully entering or present in the United States in violation of the Immigration and Nationality Act, including fugitive aliens and illegal re-entrants.

2. To support the identification and arrest of individuals (both citizens and non-citizens) who commit violations of criminal laws enforced by ICE or DHS.

3. To track the process and results of administrative and criminal proceedings against individuals who are alleged to have violated the Immigration and Nationality Act or other laws enforced by DHS.

4. To support the grant or denial of parole, and tracking of individuals who seek or receive parole into the United States.

5. To provide criminal and immigration history information during DHS enforcement encounters, and to support background checks on applicants for DHS immigration benefits (e.g., employment authorization and petitions).

6. To identify potential criminal activity, immigration violations, and threats to homeland security; to uphold and enforce the law; and to ensure public safety.

Routine uses of records maintained in the system, including categories of users and the purposes of such uses:

In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed outside DHS as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:

A. To the Department of Justice (DOJ), including Offices of the United States Attorneys, or other federal agency conducting litigation or in proceedings before any court, adjudicative, or administrative body, when it is relevant or necessary to the litigation and one of the following is a party to the litigation or has an interest in such litigation:

1. DHS or any component thereof;

2. Any employee or former employee of DHS in his/her official capacity;

3. Any employee or former employee of DHS in his/her individual capacity when DOJ or DHS has agreed to represent the employee; or

4. The United States or any agency thereof.

B. To a congressional office from the record of an individual in response to an inquiry from that congressional office made at the request of the individual to whom the record pertains.

C. To the National Archives and Records Administration (NARA) or General Services Administration pursuant to records management inspections being conducted under the authority of 44 U.S.C. 2904 and 2906.

D. To an agency or organization for the purpose of performing audit or oversight operations as authorized by law, but only such information as is necessary and relevant to such audit or oversight function.

E. To appropriate agencies, entities, and persons when:

1. DHS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised;

2. DHS has determined that as a result of the suspected or confirmed compromise, there is a risk of identity theft or fraud, harm to economic or property interests, harm to an individual, or harm to the security or integrity of this system or other systems or programs (whether maintained by DHS or another agency or entity) that rely upon the compromised information; and

3. The disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with DHS' efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.

F. To contractors and their agents, grantees, experts, consultants, and others performing or working on a contract, service, grant, cooperative agreement, or other assignment for DHS, when necessary to accomplish an agency function related to this system of records. Individuals provided information under this routine use are subject to the same Privacy Act requirements and limitations on disclosure as are applicable to DHS officers and employees.

G. To an appropriate federal, state, local, tribal, territorial, international, or foreign law enforcement agency or other appropriate authority charged with investigating or prosecuting a violation, enforcing, or implementing a law, rule, regulation, or order, when a record, either on its face or in conjunction with other information, indicates a violation or potential violation of law, which includes criminal, civil, or regulatory violations and such disclosure is proper and consistent with the official duties of the person making the disclosure.

H. To prospective claimants and their attorneys for the purpose of negotiating the settlement of an actual or prospective claim against DHS or its current or former employees, in advance of the initiation of formal litigation or proceedings.

I. To federal, state, local, tribal, territorial, or foreign government agencies, as well as to other individuals and organizations during the course of an investigation by DHS or the processing of a matter under DHS's jurisdiction, or during a proceeding within the purview of immigration and nationality laws, when DHS deems that such disclosure is necessary to carry out its functions and statutory mandates or to elicit information required by DHS to carry out its functions and statutory mandates.

J. To federal, state, local, tribal, or territorial government agencies, or other entities or individuals, or through established liaison channels to selected foreign governments, in order to provide intelligence, counterintelligence, or other information for the purposes of national security, intelligence, counterintelligence, or antiterrorism activities authorized by U.S. law, E.O., or other applicable national security directive.

K. To federal and foreign government intelligence or counterterrorism agencies or components when DHS becomes aware of an indication of a threat or potential threat to national or international security, or when such disclosure is to support the conduct of national intelligence and security investigations or to assist in anti-terrorism efforts.

L. To any federal agency to enable such agency to make determinations regarding the payment of federal benefits to the record subject in accordance with that agency's statutory responsibilities.

M. To foreign governments for the purpose of coordinating and conducting the removal of aliens from the United States to other nations under the Immigration and Nationality Act (INA); and to international, foreign, intergovernmental, and multinational agencies, authorities, and organizations in accordance with law and formal or informal international arrangements.

N. To family members and attorneys or other agents acting on behalf of an alien in immigration or other legal proceedings, to assist those individuals in determining whether: (1) The alien has been arrested by DHS for immigration violations; (2) the location of the alien if in DHS custody; or (3) the alien has been removed from the United States, released from DHS custody, or transferred to the custody of another agency, provided however, that the requesting individuals are able to verify the alien's date of birth or A-Number, or can otherwise present adequate verification of a familial or agency relationship with the alien, such as a Form G-514 or other proof of representation in a legal proceeding (e.g., notice of appearance, court appointment).

O. To the DOJ Executive Office of Immigration Review (EOIR) or its contractors, consultants, or others performing or working on a contract for EOIR, for the purpose of providing information about aliens who are or may be placed in removal proceedings so that EOIR may arrange for the provision of educational services to those aliens under EOIR's Legal Orientation Program, or for other purposes or activities within the scope of the EOIR contract.

P. To disclose information to the DOJ EOIR and to the Board of Immigration Appeals, to the extent necessary to carry out their authorized duties pertaining to the adjudication of matters arising under the INA.

Q. To attorneys or legal representatives for the purpose of facilitating group presentations to aliens in detention that will provide the aliens with information about their rights under U.S. immigration law and procedures.

R. To federal, state, tribal, territorial, or local government agencies or domestic courts to assist such agencies in collecting the repayment of loans, or fraudulently or erroneously secured benefits, grants, or other debts owed to them or to the United States Government, or to obtain information that may assist DHS in collecting debts owed to the United States Government.

S. To the Department of State in the processing of petitions or applications for benefits under the Immigration and Nationality Act, and all other immigration and nationality laws including treaties and reciprocal agreements; or when the Department of State requires information to consider or provide an informed response to a request for information from a foreign, international, or intergovernmental agency, authority, or organization about an alien or an enforcement operation with transnational implications.

T. To the Office of Management and Budget (OMB) in connection with the review of private relief legislation as set forth in OMB Circular No. A-19 at any stage of the legislative coordination and clearance process as set forth in the Circular.

U. To the U.S. Senate Committee on the Judiciary or the U.S. House of Representatives Committee on the Judiciary when necessary to inform members of Congress about an alien who is being considered for private immigration relief.

V. To federal, state, local, territorial, tribal, international, or foreign criminal, civil, or regulatory law enforcement authorities when the information is necessary for collaboration, coordination and de-confliction of investigative matters, prosecutions, and/or other law enforcement actions to avoid duplicative or disruptive efforts and to ensure the safety of law enforcement officers who may be working on related law enforcement matters.

W. To the U.S. Marshals Service (USMS) concerning USMS prisoners that are or will be held in detention facilities operated by or on behalf of ICE, and to federal, state, local, tribal, or territorial law enforcement or correctional agencies concerning individuals in DHS custody that are to be transferred to such agency's custody, in order to coordinate the transportation, custody, and care of these individuals.

X. To third parties to facilitate placement or release of an individual (e.g., at a group home, homeless shelter) who has been or is about to be released from DHS custody but only such information that is relevant and necessary to arrange housing, continuing medical care, or other social services for the individual.

Y. To a domestic government agency or other appropriate authority for the purpose of providing information about an individual who has been or is about to be released from DHS custody who, due to a condition such as mental illness, may pose a health or safety risk to himself/herself or to the community. DHS will only disclose information about the individual that is relevant to the health or safety risk they may pose and/or the means to mitigate that risk (e.g., the individual's need to remain on certain medication for a serious mental health condition).

Z. To a domestic law enforcement agency or other agency operating a sex offender registry for the purpose of providing notice of an individual's release from DHS custody or removal from the United States, when the individual is required to register as a sex offender, in order to assist those agencies in updating sex offender registries and otherwise carrying out the sex offender registration requirements within their jurisdictions.

AA. To a domestic law enforcement agency for the purpose of providing notice of an individual's release from DHS custody or removal from the United States, when the individual has a conviction(s) for a violent or serious crime(s) and the agency receiving the notification has an interest in the individual due to: (1) A pending investigation or prosecution, (2) parole or other forms of supervision, or (3) the individual's intended residence or location of release falling within the agency's jurisdiction.

BB. To victims and witnesses regarding custodial information, such as transfer to another custodial agency or location, release on bond, order of supervision, removal from the United States, or death in custody, about an individual who is the subject of a criminal or immigration investigation, proceeding, or prosecution. This would also authorize disclosure of custodial information to individuals with a legal responsibility to act on behalf of a victim or witness (e.g., attorney, parent, legal guardian) and individuals acting at the request of a victim or witness; as well as external victim notification systems that make such information available to victims and witnesses in electronic form.

CC. To the Federal Bureau of Prisons (BOP) and other federal, state, local, territorial, tribal, and foreign law enforcement or custodial agencies for the purpose of facilitating the transfer of custody of an individual to or from that agency. This will include the transfer of information about unaccompanied minor children to the U.S. Department of Health and Human Services (HHS) to facilitate the custodial transfer of such children from DHS to HHS.

DD. To DOJ and other law enforcement or custodial agencies to facilitate payments and reporting under the State Criminal Alien Assistance Program or similar programs.

EE. To any law enforcement agency or custodial agency (such as a jail or prison) to serve that agency with notice of an immigration detainer, or to update or remove a previously issued immigration detainer, for an individual who is believed to be in that agency's custody.

FF. To DOJ, disclosure of DNA samples and related information as required by 28 CFR part 28.

GG. To DOJ, disclosure of arrest and removal information for inclusion in relevant DOJ law enforcement databases and for use in the enforcement of federal firearms laws (e.g., Brady Handgun Violence Prevention Act, as amended by the NICS Improvement Amendments Act).

HH. To the attorney or guardian ad litem of an individual's child, or to federal, state, local, tribal, territorial, or foreign governmental or quasi-governmental agencies or courts, to confirm the location, custodial status, removal, or voluntary departure of an individual from the United States, in order to facilitate the recipients' exercise of responsibilities pertaining to the custody, care, or legal rights (including issuance of a U.S. passport) of the individual's children, or the adjudication or collection of child support payments or other similar debts owed by the individual.

II. To any person or entity to the extent necessary to prevent immediate loss of life or serious bodily injury, such as disclosure of custodial release information to witnesses who have received threats from individuals in custody.

JJ. To an individual or entity seeking to post or arrange, or who has already posted or arranged, an immigration bond for an alien to aid the individual or entity in (1) identifying the location of the alien; (2) posting the bond; (3) obtaining payments related to the bond; or (4) conducting other administrative or financial management activities related to the bond.

KK. To federal, state, local, tribal, territorial, or foreign government agencies or entities or multinational governmental agencies when DHS desires to exchange relevant data for the purpose of developing, testing, or implementing new software or technology whose purpose is related to this system of records.

LL. Limited detainee biographical information will be publicly disclosed via the ICE Online Detainee Locator System or any successor system for the purpose of identifying whether a detainee is in ICE custody and the custodial location.

MM. To courts, magistrates, administrative tribunals, opposing counsel, parties, and witnesses, in the course of immigration, civil, or criminal proceedings (including discovery, presentation of evidence, and settlement negotiations) and when DHS determines that use of such records is relevant and necessary to the litigation before a court or adjudicative body when any of the following is a party to or have an interest in the litigation:

1. DHS or any component thereof;

2. Any employee of DHS in his/her official capacity;

3. Any employee of DHS in his/her individual capacity when DOJ or DHS has agreed to represent the employee; or

4. The United States, when DHS determines that litigation is likely to affect DHS or any of its components.

NN. To federal, state, local, tribal, territorial, international, or foreign government agencies or entities for the purpose of consulting with that agency or entity:

1. To assist in making a determination regarding redress for an individual in connection with the operations of a DHS component or program;

2. To verify the identity of an individual seeking redress in connection with the operations of a DHS component or program; or

3. To verify the accuracy of information submitted by an individual who has requested such redress on behalf of another individual.

OO. To federal, state, local, tribal, territorial, or foreign governmental agencies; multilateral governmental organizations; or other public health entities, for the purposes of protecting the vital interests of a data subject or other persons, including to assist such agencies or organizations during an epidemiological investigation, in facilitating continuity of care, in preventing exposure to or transmission of a communicable or quarantinable disease of public health significance, or to combat other significant public health threats.

PP. To foreign governments for the purpose of providing information about their citizens or permanent residents, or family members thereof, during local or national disasters or health emergencies.

QQ. To a coroner for purposes of affirmatively identifying a deceased individual (whether or not such individual is deceased as a result of a crime) or cause of death.

RR. To a former employee of DHS for purposes of responding to an official inquiry by federal, state, local, tribal, or territorial government agencies or professional licensing authorities; or facilitating communications with a former employee that may be relevant and necessary for personnel-related or other official purposes, when DHS requires information or consultation assistance from the former employee regarding a matter within that person's former area of responsibility.

SS. To federal, state, local, tribal, territorial, foreign, or international agencies, if the information is relevant and necessary to a requesting agency's decision concerning the hiring or retention of an individual, or the issuance, grant, renewal, suspension or revocation of a security clearance, license, contract, grant, or other benefit; or if the information is relevant and necessary to a DHS decision concerning the hiring or retention of an employee, the issuance of a security clearance, the reporting of an investigation of an employee, the letting of a contract, or the issuance of a license, grant or other benefit.

TT. To a public or professional licensing organization when such information indicates, either by itself or in combination with other information, a violation or potential violation of professional standards, or reflects on the moral, educational, or professional qualifications of licensed professionals or those seeking to become licensed professionals.

UU. To an attorney or representative (as defined in 8 CFR 1.2, 202.1, 1001.1(f), or 1202.12) who is acting on behalf of an individual covered by this system of records in connection with any proceeding before U.S. Citizenship and Immigration Services (USCIS), ICE, U.S. Customs and Border Protection (CBP), or the EOIR, as required by law or as deemed necessary in the discretion of the Department.

VV. To members of the public, with regard to disclosure of limited detainee biographical information for the purpose of facilitating the deposit of monies into detainees' accounts for telephone or commissary services in a detention facility.

WW. To federal, state, local, tribal, or territorial government agencies seeking to verify or ascertain the citizenship or immigration status of any individual within the jurisdiction of the agency for any purpose authorized by law.

XX. To the Department of Justice (including Offices of the United States Attorneys) or other federal agency conducting litigation or in proceedings before any court, adjudicative, or administrative body, when necessary to assist in the development of such agency's legal and/or policy position.

YY. To federal, state, local, tribal, and territorial courts or government agencies involved in criminal investigation or prosecution, pre-trial, sentencing, parole, probation, bail bonds, or any other aspect of the criminal justice process, and to defense counsel representing an individual in a domestic criminal proceeding, in order to ensure the integrity and efficiency of the criminal justice system by informing these recipients of the existence of an immigration detainer or the individual's status in removal proceedings, including removal or custodial status/location. Disclosure of the individual's A-Number and country of birth is also authorized to facilitate these recipients' use of the ICE Online Detainee Locator System for the purposes listed above.

ZZ. To a foreign government to notify it concerning its citizens or residents who are incapacitated, an unaccompanied minor, or deceased.

AAA. To family members, guardians, committees, friends, or other agents identified by law or regulation to receive notification, decisions, and other papers as provided in 8 CFR 103.8 from the Department of Homeland Security or Executive Office for Immigration Review following verification of a familial or agency relationship with an alien when DHS is aware of indicia of incompetency or when an alien has been determined to be mentally incompetent by an immigration judge.

BBB. To an organization or person in either the public or private sector, either foreign or domestic, when there is a reason to believe that the recipient is or could become the target of a particular terrorist activity or conspiracy, or when the information is relevant to the protection of life, property, or other vital interests of a person.

CCC. To clerks and judges of courts exercising naturalization jurisdiction for the purpose of granting or revoking naturalization.

DDD. To federal, state, local, tribal, territorial, foreign, or international agencies, after discovery of such information, if DHS determines: (1) The information is relevant and necessary to that agency's decision concerning the hiring or retention of an individual, or issuance of a security clearance, license, contract, grant, or other benefit; and (2) Failure to disclose the information is likely to create a substantial risk to government facilities, equipment, or personnel; sensitive information; critical infrastructure; or public safety.

EEE. To the news media and the public, with the approval of the Chief Privacy Officer in consultation with counsel, when there exists a legitimate public interest in the disclosure of the information, when disclosure is necessary to preserve confidence in the integrity of DHS, or when disclosure is necessary to demonstrate the accountability of DHS's officers, employees, or individuals covered by the system, except to the extent the Chief Privacy Officer determines that release of the specific information in the context of a particular case would constitute an unwarranted invasion of personal privacy.

Disclosure to consumer reporting agencies:

None.

Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system:Storage:

ICE may store information in case file folders, cabinets, safes, or a variety of electronic or computer databases and storage media.

Retrievability:

ICE may retrieve records by name, biometric identifiers, identification numbers including, but not limited to, A-Number, fingerprint identification number, SSN, case or record number if applicable, case related data, or a combination of other personal identifiers including, but not limited to, date of birth, and nationality.

Safeguards:

ICE safeguards records in this system in accordance with applicable rules and policies, including all applicable DHS automated systems security and access policies. Strict controls have been imposed to minimize the risk of compromising the information that is being stored. Access to the computer system containing the records in this system is limited to those individuals who have a need to know the information for the performance of their official duties and who have appropriate clearances or permissions.

Retention and disposal:

ICE retains records of arrests, detentions, and removals in EID for one hundred (100) years; records concerning U.S. Marshals Service prisoners for ten (10) years; fingerprints and photographs collected using EAGLE application for up to fifty (50) days in the cache of an encrypted Government laptop or other IT device; Enforcement Integrated Database Data Mart (EID-DM), ENFORCE Alien Removal Module Data Mart (EARM-DM), and ICE Integrated Decision Support (IIDS) records for seventy-five (75) years; user account management records (UAM) for ten (10) years following an individual's separation of employment from federal service; statistical records for ten (10) years; audit files for fifteen (15) years; and backup files for up to one (1) month.

ICE retains records in the PCTS for 25 years from the termination of parole. The ODLS uses an extract of EID data about current detainees and detainees that were released during the last sixty (60) days. Records are retained in ODLS for as long as they meet the extract criteria. The eTD System stores travel documents for twenty (20) years. The ATD system's records are not yet the subject of a records schedule, however, ICE is in the process of developing one and will propose the records are retained for ten years from the end of the calendar year in which the alien is removed from the ATD program.

The Secretary of Homeland Security has exempted this system from the notification, access, and amendment procedures of the Privacy Act because it is a law enforcement system. However, ICE will consider individual requests to determine whether or not information may be released. Thus, individuals seeking notification of and access to any record contained in this system of records, or seeking to contest its content, may submit a request in writing to ICE's Freedom of Information Act (FOIA) Officer, whose contact information can be found at http://www.ice.gov/foia under “Contacts.” When seeking records about yourself from this system of records or any other Departmental system of records your request must conform with the Privacy Act regulations set forth in 6 CFR part 5. You must first verify your identity, meaning that you must provide your full name, current address, and date and place of birth. You must sign your request, and your signature must either be notarized or submitted under 28 U.S.C. 1746, a law that permits statements to be made under penalty of perjury as a substitute for notarization. While no specific form is required, you may obtain forms for this purpose from the Chief Privacy Officer and Chief Freedom of Information Act Officer, http://www.dhs.gov/foia or 1-866-431-0486. In addition you should provide the following:

• Explain why you believe the Department would have information on you;

• Identify which component(s) of the Department you believe may have the information about you;

• Specify when you believe the records would have been created; and

• Provide any other information that will help the FOIA staff determine which DHS component agency may have responsive records.

• If your request is seeking records pertaining to another living individual, you must include a statement from that individual certifying his/her agreement for you to access his/her records.

Without this bulleted information the component(s) may not be able to conduct an effective search, and your request may be denied due to lack of specificity or lack of compliance with applicable regulations.

In processing requests for access to information in this system, DHS/ICE will review not only the records in the operational system, but also the records that were replicated on the unclassified and classified networks, and based on this notice provide appropriate access to the information.

Record access procedures:

See “Notification procedure” above.

Contesting record procedures:

See “Notification procedure” above.

Record source categories:

Records in the system are supplied by several sources. In general, information is obtained from individuals covered by this system, and other federal, state, local, tribal, or foreign governments. More specifically, DHS/ICE-011 records derive from the following sources:

(a) Individuals covered by the system and other individuals (e.g., witnesses, family members);

(b) Other federal, state, local, tribal, or foreign governments and government information systems;

(c) Business records;

(d) Evidence, contraband, and other seized material; and

(e) Public and commercial sources.

Exemptions claimed for the system:

The Secretary of Homeland Security, pursuant to 5 U.S.C. 552a(j)(2), has exempted this system from the following provisions of the Privacy Act: 5 U.S.C. 552a(c)(3), (c)(4); (d); (e)(1), (e)(2), (e)(3), (e)(4)(G), (e)(4)(H), (e)(5), (e)(8); (f); and (g). Additionally, the Secretary of Homeland Security, pursuant to 5 U.S.C. 552a(k)(2), has exempted this system of records from the following provisions of the Privacy Act: 5 U.S.C. 552a(c)(3); (d); (e)(1), (e)(4)(G), (e)(4)(H); and (f). When a record received from another system has been exempted in that source system under 5 U.S.C. 552a(j)(2) or (k)(2), DHS will claim the same exemptions for those records that are claimed for the original primary systems of records from which they originated and claims any additional exemptions set forth here.

The Homeland Security Science and Technology Advisory Committee (HSSTAC) will meet on November 3-4, 2016 in Washington, DC. The meeting will be an open session with both in-person and webinar participation.

DATES:

The HSSTAC will meet in-person Thursday, November 3, 2016, from 10 a.m.-4:25 p.m. and Friday, November 4, 2016, from 9 a.m.-3:30 p.m.

Due to security requirements, screening pre-registration is required for this event. Please see the “REGISTRATION” section below.

The meeting may close early if the committee has completed its business.

I. Background

Notice of this meeting is given under the Federal Advisory Committee Act (FACA), 5 U.S.C. appendix (Pub. L. 92-463). The committee addresses areas of interest and importance to the Under Secretary for Science and Technology (S&T), such as new developments in systems engineering, cyber-security, knowledge management and how best to leverage related technologies funded by other Federal agencies and by the private sector. It also advises the Under Secretary on policies, management processes, and organizational constructs as needed.

II. Registration

To pre-register for the virtual meeting (webinar) please send an email to: hsstac@hq.dhs.gov. The email should include the name(s), title, organization/affiliation, email address, and telephone number of those interested in attending. For information on services for individuals with disabilities or to request special assistance at the meeting, please contact Michel Kareis as soon as possible.

If you plan to attend the meeting in-person you must RSVP by November 1, 2016. To register, email hsstac@hq.dhs.gov with the following subject line: RSVP to HSSTAC Meeting. The email should include the name(s), title, organization/affiliation, email address, and telephone number of those interested in attending.

III. Public Comment

At the end of each open session, there will be a period for oral statements. Please note that the oral statement period may end before the time indicated, following the last call for oral statements. To register as a speaker, contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

To facilitate public participation, we invite public comment on the issues to be considered by the committee as listed in the “Agenda” below. Written comments must be received by October 21, 2016. Please include the docket number (DHS-2016-0084) and submit via one of the following methods:

Instructions: All submissions received must include the words “Department of Homeland Security” and the docket number. Comments received will be posted without alteration at http://www.regulations.gov.

Docket: For access to the docket to read the background documents or comments received by the HSSTAC, go to http://www.regulations.gov and enter the docket number into the search function: DHS-2016-0084.

Agenda:Day 1: The morning session will cover updates for HSSTAC deliverables under development in the following Subcommittees: Commercialization, Social Media Working Group and IOT Smart Cities and will provide committee members an opportunity to input into the draft recommendations. A follow up discussion will be held on the request from the September webinar for contacts to be nominated for the Science Advisory Guide for Emergencies (SAGE). Science Advisory Guide for Emergencies is a tool approved as the S&T process for leadership to attain science support information concerning homeland security incidents/emergencies in order to mitigate, respond, and recover from those incidents. The second session will focus on a Quadrennial Homeland Security Review (QHSR) including an update on the material covered in the June meeting. Members will be asked to provide input into the QHSR material presented. Comments and questions from the public will follow the two morning sessions. The afternoon session will begin with a discussion led by DHS, Under Secretary for Science and Technology, Dr. Reginald Brothers on emerging threats to national security, priorities of the Under Secretary for Science and Technology, and the strategic plan for the Science and Technology Directorate. Committee members will be asked to provide feedback on the emerging national security threats. The final afternoon session will consist of discussions on the QHSR review for 2018. Members will be asked to provide input that is vital to the 2018 review and to form a subcommittee as a means to follow up on the topics discussed in more depth. This session will end with comments and questions from the public. Day 2: The morning session will begin with a briefing on the Internet of Things Smart Cities. A high value overview of the issues will be presented, followed by a discussion on best practices and lessons learned. Comments and questions from the public will follow the discussion. The afternoon session will include discussions on the 2017 HSSTAC Roadmap, science and technology topics, and issues or technology gaps that need to be addressed. The second session will cover a recap of comments from the HSSTAC, identification of a path forward for the year, and to determine if there is a need for more subcommittees on the issues discussed. There will be a period for public comment prior to adjourning the meeting.

The Bureau of Land Management (BLM) has submitted an information collection request to the Office of Management and Budget (OMB) to continue the collection of information for the location, recording, and maintenance of mining claims and sites. The Office of Management and Budget (OMB) has assigned control number 1004-0114 to this information collection.

DATES:

The OMB is required to respond to this information collection request within 60 days but may respond after 30 days. For maximum consideration, written comments should be received on or before November 18, 2016.

ADDRESSES:

Please submit comments directly to the Desk Officer for the Department of the Interior (OMB #1004-0114), Office of Management and Budget, Office of Information and Regulatory Affairs, fax 202-395-5806, or by electronic mail at OIRA_submission@omb.eop.gov. Please provide a copy of your comments to the BLM. You may do so via mail, fax, or electronic mail.

Please indicate “Attn: 1004-0114” regardless of the form of your comments.

FOR FURTHER INFORMATION CONTACT:

Sonia Santillan, at 202-912-7123. Persons who use a telecommunication device for the deaf may call the Federal Information Relay Service at 1-800-877-8339, to leave a message for Ms. Santillan. You may also review the information collection request online at http://www.reginfo.gov/public/.

SUPPLEMENTARY INFORMATION:

The Paperwork Reduction Act (44 U.S.C. 3501-3521) and OMB regulations at 5 CFR part 1320 provide that an agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. Until OMB approves a collection of information, you are not obligated to respond. In order to obtain and renew an OMB control number, Federal agencies are required to seek public comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d) and 1320.12(a)).

As required at 5 CFR 1320.8(d), the BLM published a 60-day notice in the Federal Register on March 30, 2016 (81 FR 17730), and the comment period ended May 31, 2016. The BLM received no comments.

The BLM now requests comments on the following subjects:

1. Whether the collection of information is necessary for the proper functioning of the BLM, including whether the information will have practical utility;

2. The accuracy of the BLM's estimate of the burden of collecting the information, including the validity of the methodology and assumptions used;

3. The quality, utility and clarity of the information to be collected; and

4. How to minimize the information collection burden on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other forms of information technology.

Please send comments as directed under ADDRESSES and DATES. Please refer to OMB control number 1004-0114 in your correspondence. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

Summary: The information that is collected in accordance with this control number enables the BLM to have records of mining claims and sites on Federal lands, and enables the BLM to determine which mining claims and sites claimants wish to continue to hold.

Frequency of Collection: On occasion, except Form 3830-2 (which may be filed annually) and annual FLPMA documents (which are to be filed annually when required).

Forms: Form 3830-2, Maintenance Fee Waiver Certification; and Form 3830-3, Notice of Intent to Locate a Lode or Placer Mining Claim(s) and/or a Tunnel Site(s) on Lands Patented under the Stock Raising Homestead Act of 1916, As Amended by the Act of April 16, 1993.

The Bureau of Land Management (BLM) has submitted an information collection request to the Office of Management and Budget (OMB) to continue the collection of information that enables the BLM to evaluate and process applications for commercial, competitive, and organized group recreational uses of the public lands, and individual use of special areas. The Office of Management and Budget (OMB) has assigned control number 1004-0119 to this collection.

DATES:

The OMB is required to respond to this information collection request within 60 days but may respond after 30 days. For maximum consideration written comments should be received on or before November 18, 2016.

ADDRESSES:

Submit comments directly to the Desk Officer for the Department of the Interior (OMB #1004-0119), Office of Management and Budget, Office of Information and Regulatory Affairs, fax 202-395-5806, or by electronic mail at: mailto:OIRA_submission@omb.eop.gov. Please provide a copy of your comments to the BLM via mail, fax, or electronic mail, as follows:

Please indicate “Attn: 1004-0119” regardless of the form of your comments.

FOR FURTHER INFORMATION CONTACT:

David Ballenger at 202-912-7642. Persons who use a telecommunication device for the deaf may call the Federal Information Relay Service on 1-800-877-8339, to leave a message for Mr. Ballenger. You may also review the information collection request online at http://www.reginfo.gov/public/do/PRAMain.

SUPPLEMENTARY INFORMATION:

The Paperwork Reduction Act (44 U.S.C. 3501-3521) and OMB regulations at 5 CFR 1320 provide that an agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. Until OMB approves a collection of information, you are not obligated to respond. In order to obtain and renew an OMB control number, Federal agencies are required to seek public comment on information collection and recordkeeping activities. (See 5 CFR 1320.8 (d) and 1320.12(a)).

As required at 5 CFR 1320.8(d), the BLM published a 60-day notice in the Federal Register on June 15, 2016 (81 FR 39064), and the comment period ended August 15, 2016. The BLM received no comments in response to the notice.

The BLM now invites comments on the following subjects:

1. Whether the collection of information is necessary for the proper functioning of the BLM, including whether the information will have practical utility;

2. The accuracy of the BLM's estimate of the burden of collecting the information, including the validity of the methodology and assumptions used;

3. The quality, utility and clarity of the information to be collected; and

4. How to minimize the information collection burden on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other forms of information technology.

Please send comments as instructed under the headings DATES and ADDRESSES, above. Please refer to OMB Control Number 1004-0119 in your correspondence. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

The following information is provided for the information collection:

Title: Permits for Recreation on Public Lands (43 CFR part 2930).

Forms: Form 2930-1, Special Recreation Permit Application.

OMB Control Number: 1004-0119.

Summary: This collection pertains to the management of recreation on public lands. The BLM is required to manage commercial, competitive and organized group recreational uses of the public lands, and individual use of special areas. This information allows the BLM to collect the required information to authorize and collect fees for recreation use on public lands. The currently approved information collection consists of the collection in accordance with 43 CFR part 2930, and Form 2930-1 (Special Recreation Permit Application and Permit).

The National Park Service (NPS), under its authority at 54 U.S.C. 100101(a) et seq., has prepared a new Director's Order setting forth the policies and procedures that will guide resource stewardship in the 21st century. This guidance will form a new framework for stewardship decision making within the NPS based upon an overarching resource stewardship goal described in the Order.

DATES:

Written comments will be accepted until November 18, 2016.

ADDRESSES:

Draft Director's Order #100 is available online at: http://parkplanning.nps.gov/DO100 where readers may submit comments electronically.

FOR FURTHER INFORMATION CONTACT:

Megan McKenna, Director's Order #100 Implementation Coordinator, National Park Service, at megan_f_mckenna@nps.gov, or by telephone at (970) 267-2123.

SUPPLEMENTARY INFORMATION:

The NPS is updating its current system of internal written instructions. When these documents contain new policy or procedural requirements that may affect parties outside the NPS, they are first made available for public review and comment before being adopted. Director's Order #100 and a reference manual (subsequent to the Director's Order) will be issued. The draft Director's Order covers topics such as resource stewardship, Service-wide training, and decision making.

Before including your address, telephone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

The Advisory Committee on Rules of Civil Procedure will hold a meeting on November 3, 2016, which will continue the morning of November 4, 2016, if necessary. The meeting will be open to public observation but not participation. An agenda and supporting materials will be posted at least 7 days in advance of the meeting at: http://www.uscourts.gov/rules-policies/records-and-archives-rules-committees/agenda-books.

On October 8, 2014, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, issued an Order to Show Cause to Edge Pharmacy (hereinafter, Respondent), which proposed the revocation of its DEA Certificate of Registration FE1512501, pursuant to which it was authorized to dispense controlled substances in schedules II through V, as a retail pharmacy, at the registered location of 2039 E. Edgewood Drive, Lakeland, Florida. GE 1, at 1. As ground for the proposed actions, which also include the denial of any pending applications, the Show Cause Order alleged that Respondent's “continued registration is inconsistent with the public interest.” GE 1, at 1 (citing 21 U.S.C. 824(a)(4) and 823(f)).

More specifically, the Show Cause Order alleged that Respondent's “pharmacists repeatedly failed to exercise their corresponding responsibility to ensure that controlled substances they dispensed were dispensed pursuant to prescriptions issued for legitimate medical purposes by practitioners acting within the usual course of their professional practice” and that its “pharmacists ignored readily identifiable red flags that [the] controlled substances prescribed were being diverted and dispensed despite unresolved red flags.” Id. (citing 21 CFR 1306.04(a); Holiday CVS, L.L.C., d/b/a CVS Pharmacy Nos. 219 and 5195, 77 FR 62315, 62319 (2012)). The Show Cause Order further alleged that Respondent's “pharmacists dispensed controlled substances when they knew or should have known that the prescriptions were not issued in the usual course of professional practice or for a legitimate medical purpose, including circumstances where the pharmacist knew or should have known that the controlled substances were abused and/or diverted by the customer.” Id. at 2.

The Show Cause Order then alleged that Respondent's “pharmacists filled numerous controlled substance prescriptions despite customers exhibiting multiple ‘red flags’ of . . . diversion that were never resolved before dispensing.” Id. The Order alleged that these “red flags”’ included: (1) “Multiple individuals presenting prescriptions for the same drugs in the same quantities from the same doctor”; (2) “individuals presenting prescriptions for controlled substances known to be highly abused, such as oxycodone and hydromorphone”; (3) “individuals paying high prices . . . for controlled substance [prescriptions] with cash”; and (4) “individuals residing long distances from the pharmacy.” Id.

As more specific examples, the Show Cause Order alleged that “[o]n January 10, 2011, one or more . . . pharmacists dispensed large and substantially similar quantities of” oxycodone 30 mg tablets “to at least nine persons, including one customer who resided more than four hundred (400) miles from [it], two customers who resided more than one hundred fifty (150) miles from [it], and six customers who resided more than ninety (90) miles from” it. Id. The Order further alleged that these “customers were all prescribed thirty milligram tablets of oxycodone by the same doctor in quantities ranging from 168 to 224 tablets” and that each of the prescriptions was “facially invalid” because it did not contain the patient's address. Id.

The Show Cause Order also alleged that “[f]rom January 6 through January 7[,] 2011, one or more . . . pharmacists dispensed large and substantially similar quantities of” oxycodone 30 mg tablets “to at least sixteen persons, including eight customers who resided more than one hundred fifty (150) miles from [it], and four customers who resided more than one hundred (100) miles from” it. Id. The Order further alleged that “these customers were all prescribed thirty milligram tablets of oxycodone by the same doctor in quantities ranging from 168 to 224 tablets” and that each of the prescriptions was “facially invalid” because it did not contain the patient's address. Id.

Next, the Show Cause Order alleged that “[f]rom October 7 through October 28[,] 2011, one or more . . . pharmacists dispensed large and substantially similar quantities of hydromorphone to seventeen [persons], ten of whom resided more than one hundred (100) miles from” it, and “two of whom resided more than four hundred (400) miles away.” Id. The Order alleged that “sixteen” of these prescriptions “were written by the same doctor and only one . . . contained a patient address.” Id. The Order then alleged that “at least four” of the hydromorphone prescriptions were “in dosage amounts that, if taken as directed, far exceeded the recommended dosages of hydromorphone that should be taken on a daily basis” and that “[t]hese prescriptions were dispensed on October 21 and 27[,] 2011” and July 5-6, 2012. Id.

The Show Cause Order also alleged that “[f]rom January 4 through 23[,] 2013, one or more . . . pharmacists dispensed large quantities of” of oxycodone 30 mg “to at least” 19 persons, 15 “of whom resided more than 90 miles from [it] and eight of whom resided more than [150] miles away.” Id. at 3. The Order alleged that “[a]ll of these prescriptions were issued by the same doctor, and were purchased with cash by individuals willing to pay as much as eight dollars per tablet.” Id. The Order also alleged that these prescriptions were facially invalid because they lacked the patient's address. Id.

The Show Cause Order then alleged that Respondent's “pharmacists knew or should have known that the vast increase of customers seeking controlled substance prescriptions and the large number of customers residing long distances from [its] location and/or their respective physicians created a suspicious situation requiring increased scrutiny, and nonetheless failed in carrying out their responsibilities as a DEA registrant.” Id. Continuing, the Order alleged that Respondent's “pharmacists failed to exercise their corresponding responsibility” under 21 CFR 1306.04(a) in dispensing controlled substances and either “knew, or should have known, that a large number of the prescriptions for controlled substances that it filled were not issued for a legitimate medical purpose or were issued outside the usual course of professional practice.” 1Id. (citing cases).

1 In its Prehearing Statement, the Government provided notice that its expert witness in pharmacy practice would identify various red flags of diversion that were presented by the prescriptions “and that there is no evidence that any of the red flags were resolved prior to distributing the controlled substances to the customers.” Gov. Prehearing Statement, at 5. Subsequently, in its Supplemental Prehearing Statement, the Government provided notice that its Expert “will opine on 127 additional prescriptions which the Government provided to Respondent's counsel” and “that the prescriptions were issued to individuals residing long distances both from Respondent's pharmacy and/or the physician who issued the prescriptions.” Gov. Supplemental Prehearing Statement, at 3.

After identifing various cities where the patients resided, the Government provided notice that its Expert “will testify that this type of red flag, with only a few exceptions, is not resolvable and the prescription should not be dispensed by a pharmacist exercising the appropriate standard of care and fulfilling his or her corresponding responsibility to ensure that a prescription for a controlled substances is issued for a legitimate medical purpose.” Id. at 3-4. The Government also provided notice that its Expert will testify that “exceptions” [sic] that would make such a prescription resolvable were “if a patient were travelling to a specialist of great renown, such as a physician working in a nationally recognized cancer treatment facility.” Id. at 3 n.4. The Government then provided that its Expert “will testify that he is unaware that any of the physicians prescribing the controlled substances at issue in this matter remotely fit that profile.” Id.

Next, the Show Cause Order alleged that following the execution of an Administrative Inspection Warrant, DEA had obtained various records from Respondent and determined that it “failed to create and maintain accurate records in violation of 21 U.S.C. 842(a)(5).” Id. at 3. More specifically, the Order alleged that:

(1) Respondent's schedule II order forms did not contain the “receipt date or quantity received in violation of 21 U.S.C. 827(b) and 21 CFR 1305.13(e)”;

(3) it “failed to create a record of the quantity of each item received and the date received” for controlled substances it ordered using the Controlled Substances Ordering System and “also failed to electronically archive and link these records to the original order,” both being required by 21 CFR 1305.22(g);

(4) that “as supplier of controlled substances, [it] failed to forward Copy 2 of” schedule II order forms to the Special Agent in Charge of the field division in which it is located, as “required by 21 CFR 1305.13(d)”; and

(5) it also “failed to record the date and quantity shipped” on schedule II order forms, “in violation of 21 CFR 1305.13(b).” Id. at 3-4.

Finally, the Show Cause Order alleged that DEA conducted an audit of Respondent's handling of various schedule II drugs for “the period [of] June 10, 2011, through February 4, 2013.” Id. at 4. The Order then alleged that the audit found overages of the following drugs and amounts: 71,084 oxycodone 30 mg; 19,322 hydromorphone 8 mg; 10,460 methadone 10 mg; 5,542 morphine 60 mg; 4,451 hydromorphone 4 mg; 3,033 morphine 100 mg; and 1,338 morphine 30 mg. Id.

On November 14, 2014, Respondent filed a timely hearing request with the Office of Administrative Law Judges. Thereafter, the matter was assigned to Chief Administrative Law Judge John J. Mulrooney, II (hereinafter, CALJ), who proceeded to conduct extensive pre-hearing procedures. On February 19, 2015, Respondent's original counsel withdrew and new counsel entered an appearance. The same day, Respondent's new counsel informed the ALJ's law clerk that Respondent would be “filing a waiver of hearing along with a written position on the matters of fact and law in accordance with 21 CFR 1316.49.” GE 1, at 10.

Subsequently, on February 26, 2015, the Government filed a motion in limine to preclude Respondent from offering any of its evidence at the hearing. Respondent did not oppose the motion, and on March 3, 2016, the ALJ granted the motion. Letter from CALJ to the former Administrator (Mar. 23, 2015) (hereinafter, CALJ Ltr.). The same day, Respondent's counsel telephoned the CALJ's staff and stated that he would be filing its waiver of hearing by March 9, 2015, and that if he “was unable to file the Hearing Waiver by that date, he would file a motion to allow a waiver of hearing with a subsequent filing of position.” Id. However, on March 10, 2015, after Respondent failed to file the waiver or otherwise notify the ALJ as to why he had not done so, the CALJ's staff contacted Respondent's counsel to seek clarification. Id.

On March 12, 2015, before the evidentiary hearing was to be conducted, Respondent's counsel emailed the CALJ's staff stating that he had not filed the hearing waiver because he had been unable to complete the written statement “[d]ue to several unforeseen matters in” another DEA proceeding in which he was involved. Email from Respondent's Counsel to CALJ's Law Clerk, at 1 (Mar. 12, 2015). Respondent's counsel further advised that he had not sought leave to file the waiver immediately and the statement of position later because the Government's counsel would not consent. Id. Respondent's counsel further represented that while he intended to file the waiver prior to the scheduled date of the hearing, he would not file the waiver until he was ready to file Respondent's written statement of position. Id.

On March 16, 2015, the CALJ conducted a status conference after which Respondent's counsel filed a pleading in which Respondent waived its right to a hearing while seeking leave to file a written statement no later than March 21, 2015. CALJ Ltr., at 2. The CALJ then issued an order terminating the proceeding effective on March 21, 2015 while granting Respondent leave to file its written statement prior to that date. Id.

On March 20, 2015, Respondent filed its Statement of Position. In his March 23, 2015 letter to the former Administrator regarding the status of the proceeding, the CALJ noted that under the plain language of the Agency's regulation which allows a respondent to file a written statement of position, the time period for filing a written statement had expired as Respondent had not requested an extension of the time for filing a response to the Order Show Cause. Id. at 3. Moreover, because Respondent did not oppose the Government's Motion in Limine, “it is foreclosed from offering hearing evidence.” Id.

The CALJ then explained that “strict adherence to the regulations, because of the procedural choices made by the Respondent in the course of this litigation, would result in either a non-hearing decision without the option of filing a statement of position, or hearing procedures where it was precluded (by its own tactical choices) of presenting evidence in its defense.” Id. Continuing, the ALJ reasoned that:

[a]lthough the Agency . . . has not been reticent in holding respondents responsible for the procedural omissions of their counsel, justice here will be better served by applying principles of reasonableness. In the interests of justice, I sua sponte find good cause to extend the Respondent's ability to respond to the Order to Show Cause in accordance with 21 CFR 1316.47(b), accept its Statement of Position on the Agency's behalf, and herein forward it to you for whatever consideration or actions (if any) you deem appropriate in this matter. Id. (footnotes omitted).

Thereafter, the Government filed a motion in which it sought to clarify its obligations prior to submitting its Request for Final Agency Action. More specifically, the Government sought clarification as to whether, in light of Respondent's waiver of its right to a hearing, it was required to serve any further pleadings on Respondent's counsel. Motion for Clarification, at 1. It also sought clarification as to whether Respondent was “entitled to continue to litigate this matter” given the waiver. Id. at 1-2.

Respondent objected to the Government's motion. Resp. Objection to Motion for Clarification. In its objection, Respondent argued that while it had waived its right to a hearing, it was entitled to otherwise participate in the proceeding which was ongoing and to receive copies of any filings submitted by the Government and respond to them. Id. at 2-3.

Respondent also asserted that while “the Government was similarly entitled to participate in the proceeding, it chose not to do so and opted to sit in silence when Respondent submitted its evidence and [written] position . . . [and] when the ALJ unambiguously announced his intention to terminate the proceeding upon receipt of Respondent's position.” Id. at 3-4. In Respondent's view, the Government was entitled to participate in the hearing and “could have objected [sic] cancellation of the hearing” or “could have presented its evidence in writing.” Id. at 8. Respondent further maintained that the Government, by failing to present its evidence to the CALJ, “allow[ed] the record before the ALJ to close without presenting [its] case.” Id. Respondent also argued that this Decision and Order “must be based on [the] record” submitted by the CALJ and that because that record contains no evidence to support the allegations, the Government had not met its burden of proof. Id. at 9-10.

On review, I determined that it was unnecessary to decide whether either the Administrative Procedure Act or the Due Process Clause requires the Government to submit copies of any subsequent filings to Respondent. Order, at 3 (July 29, 2015). Rather, I exercised my discretion and directed the Government to provide a copy of its Request for Final Agency Action and the record submitted in support of its Request to Respondent. Id. at 3-4. Based on Respondent's waiver of its right to hearing, I concluded that Respondent had waived its right to submit evidence in refutation of the Government's case. Id. at 4. However, I again exercised my discretion and provided that Respondent could file a brief raising arguments challenging the sufficiency of the evidence, the Government's positions on matters of law, and the appropriate sanction. Id.

However, I rejected Respondent's contention that the Government was not allowed to continue litigating the matter because it chose to forgo making a record before the ALJ.2Id. at 4 n.2. Moreover, finding the reasons proffered by the CALJ insufficient to support a finding to excuse the untimely submission of its Statement of Position, I directed Respondent to address “why there is good cause to excuse the untimeliness of its filing, paying particular attention as to why there is good cause to excuse the untimely submission of the attached affidavits.” Id. And because the CALJ had issued an order terminating the proceeding effective March 21, 2015 and the CALJ did not rule on whether there was good cause to admit Respondent's Statement of Position until March 23, 2015 (after his jurisdiction had terminated pursuant to his own order), I directed Respondent to “address whether, given the effective date of the ALJ's termination order, the ALJ had authority to admit its Statement of Position.” Id.

2 I also rejected Respondent's contention that the Government had no procedural basis for requesting clarification and that I had no authority to respond to that motion. I did not, however, set forth my reasoning for rejecting these contentions.

Thereafter, Respondent filed a letter responding to my Order. Letter from Resp's. Counsel to the Acting Administrator (Aug. 7, 2015). Therein, Respondent asserted that it had faxed its Written Statement of Position on March 20, 1015, which is borne out by the fax cover sheet.3Id. at 1-2. As for whether there was good cause to accept its Written Statement of Position, Respondent argues that the CALJ erred in relying on 21 CFR 1301.43 when he concluded that it was foreclosed from filing its written statement of position because the time period for filing its hearing request had passed. Id. at 3. Respondent argues that after it filed its hearing request under 21 CFR 1301.43(a), the provisions of part 1301 no longer apply and the provisions of part D of 21 CFR part 1316 are controlling. Id. It further argues that 21 CFR 1316.49, the provision of Subpart D which applies to the waiver of a hearing, “contains no provision for cancellation of the hearing” and that “no provision in Subpart D . . . indicat[es] the time period within which [it] may waive its opportunity to participate in the hearing and file its written statement.” Id. In Respondent's view, it has been denied “fair notice” that “having requested a hearing, it had to waive its opportunity to participate in a hearing and file its Statement . . . within 30 days of being served with the” Show Cause Order. Id. And Respondent argues that the requirement that it file its written statement within 30 days of the date on which it was served with the Show Cause Order “does not apply to a waiver and written statement filed after requesting a hearing.” Id.

3 In his letter, Respondent devoted considerable argument to discussing why portions of the fax were date stamped after the deadline imposed by the CALJ. That, however, was not the issue, and was not mentioned in my July 29, 2015 Order.

I reject these contentions because Respondent is simply trying to re-write the Agency's procedural rules to suit its own purpose. Under the Agency's rules, a person served with a Show Cause Order has two options for responding to it.4 First, it can, “within 30 days after the date of receipt of the order to show cause,” file a request for a hearing as Respondent initially did. 21 CFR 1301.43(a). Alternatively, it can, “within the period permitted for filing a request for a hearing, file with the Administrator a waiver of an opportunity for a hearing . . . together with a written statement regarding such person's position on the matters of fact and law involved in such hearing.” Id. § 1301.43(c). See also id. § 1316.49 (“Any person entitled to a hearing may, within the period permitted for filing a request for a hearing . . . waiver of an opportunity for a hearing, together with a written statement regarding his position on the matters of fact and law involved in such hearing.”).5

4 Of course, a person served with a Show Cause Order can also choose to not respond.

5 While the wording of this provision clearly reflects a scrivener's error in that it is missing language to the effect that the person “may file a” waiver and written statement, it has never been construed as creating a right to file a written statement at any time thereafter.

Contrary to Respondent's contention, both the procedural rules found in 21 CFR part 1301 and Part 1316 apply to hearings conducted under 21 U.S.C. 823 and 824. See 21 CFR 1301.41(a) (“In any case where the Administrator shall hold a hearing on any registration or application therefore, the procedures for such hearing shall be governed generally by the adjudication procedures set forth in the Administrative Procedure Act (5 U.S.C. 551-559), and specifically by [21 U.S.C. 823-24], by §§ 1301.42-1301.46 of this part, and by the procedures for administrative hearings . . . set forth in §§ 1316.41-1316.67 of this chapter.”).6 Thus, while Respondent argues that no regulation in part 1316 provides for the cancellation of a hearing, Part 1301 contains a provision which states that “[i]f all persons entitled to a hearing . . . waive or are deemed to waive their opportunity for the hearing . . . the Administrator may cancel the hearing, if scheduled, and issue his/her final order pursuant to 1301.46 without a hearing.” 21 CFR 1301.43(e). Thus, contrary to Respondent's understanding, this provision applies to its waiver, notwithstanding that it had previously requested a hearing. In any event, given that a hearing is only held on request of “a person entitled to a hearing” and is held “for the purpose of receiving factual evidence regarding the issues involved in the denial, revocation or suspension of any registration,” 21 CFR 1301.42, it is indisputable that a hearing can be cancelled when a respondent initially requests a hearing but then decides to waive its right to it.

6See also 21 CFR 1316.41 (“Procedures in any administrative hearing held under the Act are governed generally by the rule making and/or adjudication procedures set forth in the [APA] and specifically by the procedures set forth in this subpart, except where more specific regulations [set forth in other parts including parts 1301] apply.”).

Nor am I persuaded by Respondent's contention that it has been denied fair notice because once it requested a hearing, no provision in Subpart D sets forth the time period in which it was required to file its written statement if it subsequently decided to waive its right to a hearing. Resp's. Ltr., at 3. The Agency's regulations grant the right to file a written statement only when a hearing waiver is filed within the 30-day period or where a respondent establishes “good cause” for the untimely filing. 21 CFR 1301.43(d). Thereafter, no provision in the Agency's hearing regulations affords a respondent the right to file a written statement of position and to submit evidence. Given that the Agency's regulations do not provide any right to file a written statement after the initial 30-day period for responding to the Order to Show Cause, Respondent cannot claim that it has been denied “fair notice” that it had to submit its hearing request within the 30-day period.

Thus, while the Controlled Substances Act requires the Agency to provide a hearing conducted pursuant to the APA's procedures for adjudications, see 21 U.S.C. 824(c), the Agency provided Respondent with that opportunity and was prepared to provide it with that hearing. At that hearing, Respondent could have challenged the Government's evidence through, inter alia, the cross-examination of its witnesses. Respondent could also have presented evidence in its defense had it complied with the ALJ's pre-hearing orders. In short, the Agency is not required to provide Respondent with more procedural rights than Congress mandated in the CSA. Cf. Vermont Yankee Nuclear Power Corp. v. NRDC, 435 U.S. 519 (1978). And while the Agency has provided a limited right to submit a written statement, the Agency is not required to create a new procedural right to provide Respondent, which waived its right to a hearing only after months of largely unsuccessful pre-hearing litigation, with an alternative way of presenting evidence.

Respondent further argues that applying 21 CFR 1301.43 (the regulation requiring the filing of a written statement within 30 days of receipt of the Show Cause Order) to its circumstances, “produces a result contrary to the Agency's interest in administrative efficiency.” Resp's. Ltr., at 3. It argues that under the ALJ's interpretation, “respondents who have made a timely request for hearing but later realize that they have no need or desire to participate in a hearing would be left with two choices: Continue to require the Agency to hold a hearing or abandon all opportunity to be heard in any manner whatsoever.” Id. Respondent further argues that faced with this choice, “such respondents would be strongly discouraged from waiving an unnecessary hearing and preventing a waste of Agency time and resources.” Id. at 3-4.

This choice is, however, no different than that frequently confronted in litigation when a party recognizes that his opponent has a strong case and is likely to prevail at trial. Moreover, Respondent's proposed new procedural right would actually create the opposite incentive: Instead of submitting its written statement at the outset, it induces a respondent to litigate, knowing that if things go badly, it can then take a different tack by submitting its written statement. Moreover, in Respondent's view, it is also entitled to submit testimonial evidence in the form of affidavits and thus preclude the Government from cross-examining its witnesses.

Upon receipt of a Show Cause Order, a party is entitled to fair notice of the factual and legal basis for the actions proposed by the Government. 21 U.S.C. 824(c). And where a respondent chooses to litigate, the Government is obligated to provide a respondent with fair notice of the evidence it is likely to confront at the hearing. However, creating a new procedural right that allows a party, which has litigated for months on end, to then waive its right to a hearing on the eve of that hearing but nonetheless present its evidence in written form, does not in any sense promote administrative efficiency. To the contrary, it incentivizes litigation by providing two bites of the apple.7

7 Unexplained by Respondent is whether, in its view, there is any limit to when it could waive its right to a hearing and submit a written statement. For example, could it require the Government to put on its case in chief, determine how strong the case was, and then waive its right to a hearing and submit a written statement?

Respondent also takes issue with the CALJ's application of the “good cause” standard in evaluating whether it Statement was timely submitted. Resp's. Ltr., at 4. And it further argues that even if the “good cause” standard applies, it has satisfied the standard. Id. I disagree.

As explained above, the two Agency rules that granted Respondent the right to file a written statement required it do so within the 30-day period for requesting a hearing. Putting that aside, DEA has applied the “good cause” standard in a variety of contexts in assessing whether an untimely filing should be excused, including to the untimely submission of a statement of position. See Ronald A. Green, 80 FR 50031 (2015) (deeming physician's pleading captioned as “Response to First Amended Complaint and Motion to Dismiss,” which was filed with the Agency more than three months after service of Show Cause Order as his statement of position, and applying “good cause” standard in assessing whether it was timely filed); see also Rene Casanova, 77 FR 58150, 58150 (2012) (upholding ALJ's application of good cause standard in denying untimely filed request for an extension to file exceptions); Daniel B. Brubaker, 77 FR 19322, 19323 (2012) (upholding ALJ's application of good cause standard in denying untimely motion to file supplemental prehearing statement out of time); Kamir Garces-Mejias, 72 FR 54931, 54932-33 (2007) (applying good cause standard in upholding ALJ's termination of hearing where respondent failed to comply with ALJ's order to file pre-hearing statement). See also 21 CFR 1301.43(d) (applying good cause standard in assessing whether an untimely hearing request should be excused); id. 1316.57 (“All documentary evidence and affidavits not submitted and all witnesses not identified at the prehearing conference shall be submitted or identified to the presiding officer as soon as possible, with a showing that the offering party had good cause for failing to so submit or identify at the prehearing conference.”).

Respondent further argues that even if the good cause standard applies to the submission of its written statement, it has satisfied the standard because the Agency has interpreted the standard “with reference to case law” applying the excusable neglect standard, and under that standard, it has demonstrated good cause. Resp's. Ltr., at 4. Respondent is correct that the Agency has interpreted the good cause standard in a manner that aligns it with the good cause standard of various federal rules of procedure. See Keith Ky Ly, 80 FR 29025, 29027-28 & n.2 (2015). Thus, Respondent's untimely filing of its Statement may be excused upon a showing of excusable neglect. Respondent, however, has failed to show excusable neglect.

As the basis of its argument, Respondent's counsel argues that he did not become counsel for Respondent until February 2015 when original counsel withdrew, at which time he “discovered that the DEA had refused to return Respondent's records in violation of Agency policy and the clear directions of the Magistrate Judge who issued the administrative inspection warrant.” Resp's. Ltr., at 4. He further maintains that he “also discovered that the scanned images of those documents which had been provided to Respondent contained annotations that were not on the records when the DEA removed them from the pharmacy [and] also found the images to be illegible in part.” Id. Continuing, he argues that “[i]t was impossible for Respondent to know within 30 days of receiving the Order to Show Cause that the Government would rely on portions of the documents that the DEA refused to return to Respondent, since the Government first revealed this on December 2, 2014 when [Government counsel] filed the Government's prehearing statement.” Id. According to Respondent's counsel, he “determined that a hearing under these circumstances would be futile” and Respondent decided to waive its right to a hearing.8Id.

8 Respondent's counsel also devotes considerable discussion to the give and take between himself and Government counsel over the timing and filing of his written statement after he appeared in the proceeding. The discussion, however, adds nothing either way in determining whether Respondent has met the good cause standard as Respondent had been served with the Show Cause Order four months before it hired new counsel, and Respondent's prior counsel filed numerous pleadings on its behalf up until he withdrew.

These arguments do not establish excusable neglect (or any other form of good cause), and certainly not with respect to Respondent's delay in filing its statement until approximately five months after it was served with the Show Cause Order. As for the contention that the Agency violated “the clear directions of the Magistrate Judge” because it refused to return the records to Respondent, Respondent does not identify any language in the Administrative Inspection Warrant which set a date by which the Government was required to return its records. Nor does it identify any court order issued by the Magistrate Judge requiring the return of the records with which the Government failed to comply.9 As for Respondent's claims that some of the documents contained notations that were not on them when they were seized and that some of the documents were “illegible in part,” Respondent has not even identified which documents have these characteristics, let alone explain why these documents were relevant to the specific allegations raised by the Government. Moreover, to the extent the Government intended to rely on any document that was purportedly illegible, Respondent offers no explanation for why its previous counsel did not seek legible copies.

9 The warrant required only that a prompt return of the warrant itself be made. It appears that copies of the records were provided to Respondent's original counsel on October 16, 2014, the date on which Respondent was served with the Show Cause Order.

Also unpersuasive is Respondent's assertion that “[i]t was impossible for [it] to know within 30 days of receiving the [Show Cause] Order that the Government would rely on portions of the documents that the DEA refused to return to” it and that it did not know what documents it would rely on until December 2, 2014, when the Government filed its prehearing statement. The CALJ, however, granted Respondent an extension of time to allow it to file its prehearing statement on January 2, 2015, which it did. Moreover, even if Respondent did not know what documents the Government intended to rely on until December 2, 2014, this does not explain why Respondent then waited another three and a half months to file its written statement.

I further reject the contention that these circumstances rendered the hearing futile. Indeed, in cases brought against two related pharmacies which Respondent's current counsel also participated in and made similar arguments regarding the Government's purported unlawful retention of its records, I rejected the Government's dispensing allegations as unsupported by substantial evidence. See Superior Pharmacy I and Superior Pharmacy II, 81 FR 31310, 31334-337 (2016). I also rejected various recordkeeping allegations as not being supported by either the CSA or DEA regulations. Id. at 31338. And while I accepted the Government's audit allegations in Superior, I noted that the respondents had approximately 80 days from the date on which they were served with the show cause orders (at which time they also were provided with copies of their records) to file their prehearing statements and had ample time to conduct their own investigation of the allegations. Id. at 31337 n.62.

Notably, in the Superior matters, the respondents made similar arguments with respect to the audits and yet they provided charts which purported to show the results of their own audits when they filed their untimely exceptions to the ALJ's Recommended Decision. In declining to consider this evidence, I noted that there was no foundation for its consideration and that it was not newly discovered evidence; I also observed that Respondent “did not identify any records that were necessary to complete their audits which were not provided to them when their records were returned.” Id. So too here. Notably, as part of Respondent's Statement of Position, it submitted the affidavit of Victor Obi, the brother of Respondent's owner (and the owner of the two Superior Pharmacies), who avers that he is Respondent's independent pharmacy consultant. Resp.'s Position Statement, Attachment 3, at 1.

In the affidavit, Mr. Obi avers that he reviewed the purchasing, return and dispensing records for the pharmacy for the same audit period as used by the Government; Obi further avers that he conducted an audit of the various drugs and dosage strengths audited by the Government and disputes the results of the Government's audit for the various drugs. Id. at 3-6. Notably, Obi executed the affidavit on March 20, 2015. Id. at 6. Unexplained by Respondent is why Mr. Obi was unable to complete his audit before the date by which it was required to file its prehearing statement, or a supplemental prehearing statement which it could have filed without leave of the CALJ if it did so before 2 p.m. on February 20, 2015. See Preliminary Order Regarding Scope of Proceedings, Prehearing Ruling, & Protective Order, at 7 (Jan. 13, 2015).

Of further note, in its Pre-hearing Statement, Respondent represented that it intended to call a witness who was a former DEA Diversion Program Manager who “will testify regarding errors in the audits performed by the agents/investigators involved in the investigation of Edge Pharmacy.” Resp. Prehearing Statement, at 5. Presumably, Respondent's prior counsel would not have made this representation without the proposed witness having conducted an investigation of the audit allegations and found that there were errors. Yet when the Government field its Motion in Limine to preclude this witness's testimony on the ground that Respondent had “fai[ed] to identify a single error” in the audits, Motion in Limine, at 6; Respondent's new counsel did not oppose the motion, thus suggesting that this proposed witness had not, in fact, performed an audit.

Notably, Respondent's conclusion that a hearing would have been “futile” came only after months of pre-hearing litigation, and to the extent the hearing would have been futile, this was largely the result of the strategic choices made by its counsel. Although the record does not establish when Mr. Obi finally performed his audit, Respondent clearly had ample time to investigate the allegations and disclose its proposed evidence prior to the hearing if it believed the allegations were untrue. And while Respondent's prior counsel may well have been neglectful in failing to thoroughly investigate the allegations, that neglect is not excusable. See Pioneer Inv. Servs. Co. v. Brunswick Assoc. Limited Partnership, 507 U.S. 380, 397 (1993) (one who “voluntarily chose [its] attorney as [its] representative in the action . . . cannot . . . avoid the consequences of the acts or omissions of this freely selected agent. Any other notion would be wholly inconsistent with our system of representative litigation, in which each party is deemed bound by the acts of [its] lawyer-agent and is considered to have notice of all facts, notice of which can be charged upon the attorney”) (int. quotation and citation omitted). See also U.S. v. $29,410.00 in U.S. Currency, 600 Fed. Appx. 621, 623-24 (10th Cir. 2015) (excusable neglect not established where counsel failed to respond to an answer or interrogatories for over three months and offered no reasonable explanation); Brodie v. Gloucester Township, 531 Fed. Appx. 234, 237 (3d Cir. 2013) (excusable neglect not established to support extension of time to file notice of appeal when client's counsel “could have filed a notice of appeal, but chose not to do so”); A.W. Anderson v. Chevron Corp., 190 FRD. 5, 10 (D.D.C. 1999) (failure to oppose motion for attorneys' fees not excusable neglect when “[t]he decision . . . was by any measure a calculated decision by [p]rior [c]ounsel”); see also id. at 11 (client “bound by the strategic choices of her counsel that later turn out to be improvident”) (citing Douglas v. Kemp, 721 F.Supp. 358 (D.D.C. 1989)).

Nor has Respondent otherwise demonstrated good cause for filing its written statement more than four months after the fact.10 Notably, in accepting Respondent's written statement, the CALJ noted that “because of the procedural choices made by Respondent in the course of the litigation,” specifically, its decision not to oppose the Government's Motion in Limine and its failure to file its written statement within the time allowed by the regulations, Respondent would be foreclosed from putting forward its defense. CALJ Ltr., at 4. Invoking 21 CFR 1316.47(b), the CALJ, notwithstanding his previous discussion of Respondent's procedural choices, then asserted that the interests of justice “will be better served by applying principles of reasonableness” and found, sua sponte, that there was good cause to extend Respondent's ability to respond to the Order to Show Cause and accepted its statement on the Agency's behalf. Id. (citing 21 CFR 1316.47(b)).

10 Respondent could also have sought an extension of time to respond to the Show Cause Order, and upon a showing of good cause, the ALJ could have granted a reasonable extension of time to do so. 21 CFR 1316.47(b). However, Respondent did not avail itself of this provision.

Under this regulation, “[t]he Administrative Law Judge, upon request and showing of good cause, may grant a reasonable extension of the time allowed for response to an Order to Show Cause.” 21 CFR 1316.47(b) (emphasis added). However, as explained above, in his August 7, 2015 filing, Respondent asserted that this provision does not apply to the filing of its written statement even though the statement is now its “response to” the Show Cause Order, and in any event, Respondent never requested an extension of time to file its written statement. In short, the plain language of this provision does not contemplate sua sponte rulings by the ALJ. Rather, it explicitly requires that the respondent in a proceeding seek an extension and imposes on a respondent the affirmative obligation to show “good cause,” neither of which were done here.

I am also unpersuaded by Respondent's after-the-fact assertion that there was good cause (in response to my Order) to excuse its belated filing because it could not prepare its Statement of Position until December 2, 2014, when the Government filed its Pre-Hearing Statement and notified it of what documents were to be used as evidence. Resp.'s Ltr., at 6. As set forth above, the regulation authorizes the granting of only “a reasonable extension of time.” 21 CFR 1316.47(b). While the reasonableness of an extension is dependent on the circumstances, here, Respondent's showing does not establish that it needed three and a half months after this date to file its written statement, and the extension clearly exceeds the bounds of reasonableness.

To be sure, in Leonard Browder, d/b/a Lominick's Pharmacy, Family Pharmacy, Inc., Aiken Drug Co., Woodruff Drug Co., 57 FR 31214 (1992), the Agency's Decision noted that it had considered a respondent's statement of position, notwithstanding that it was not submitted until a year and a half after the respondent initially requested a hearing and after negotiations to settle the matter were unsuccessful. The decision is, however, bereft of any discussion as to the basis for accepting the respondent's statement of position and the then-applicable regulations, and thus, the decision is of limited precedential value.11 No subsequent decision of the Agency has cited Browder, and as explained above, the Agency has long since made clear that the “good cause” standard is to be applied in determining whether to accept an untimely filing.

11 For example, in Browder, the Government may have consented to the filing, thus rendering it unnecessary for the respondent to establish good cause.

In accepting Respondent's statement, the CALJ also explained that he was “applying principles of reasonableness.” However, as explained above, courts generally do not allow parties to escape the consequences of deliberate strategic decisions made by their lawyers in litigation. See Pioneer, 507 U.S. at 397; $29,410.00 in U.S. Currency, 600 Fed. Appx. at 623-24; Brodie, 531 Fed. Appx. at 237; A.W. Anderson v. Chevron Corp., 190 FRD. at 10. Here, Respondent had ample opportunity to investigate the allegations and prepare a defense. Moreover, even after it failed to oppose the Government's Motion in Limine, it nonetheless could have gone to hearing, where it could have cross-examined the Government's witnesses and attempted to show that the Government's evidence was not reliable.

In short, the Agency's procedural rules are clear and provided Respondent with ample means to protect its interests.12 It could have filed its written statement within 30 days of receipt of the Show Cause Order. If Respondent had shown “good cause,” it could have filed its written statement even beyond the 30-day period for requesting a hearing if it did so within a reasonable period of time but not months later. And it could have gone to a hearing. Respondent does not, however, have the right to re-write the Agency procedural rules to fit its litigation strategy.13

12 In its August 7, 2015 response to my Order, Respondent argued that the untimely filing of its Statement of Position does not prejudice the Government. Yet, as explained later in this Decision, in its Objection to the Government's Motion for Clarification, Respondent claims that the record is now closed (Objection, at 7), because the Government failed to object to the cancellation of the hearing. It further argues that because the Government did not submit a statement of position to the CALJ, his “report includes no evidence or argument in favor of the Government's case” and thus, “[t]he Government failed to carry the burden of proof assigned to it.” Id. at 9. As Respondent Objection's make clear, its purpose in submitting its untimely Statement of Position is to prejudice the Government.

13 In his letter to the former Administrator, the CALJ set forth in detail the procedural events which occurred from the date Respondent's former counsel withdrew and Respondent's new counsel entered an appearance, the various representations made by Respondent's new counsel, and as the CALJ explained, “the failure on the part of Respondent's (new) counsel to honor the commitments made to the tribunal.” CALJ Letter, at 2.

In my Order addressing the Government's Motion for Clarification, I held that because Respondent had waived its right to a hearing, it had waived its right to submit any evidence in refutation of the Government's case.14 I further deemed it unnecessary to decide whether, under the Agency's regulations (21 CFR 1301.43), Respondent's waiver of its right to a hearing also precludes it from challenging the sufficiency of the Government's evidence, as well as the Government's position on matters of law and the appropriate sanction. Instead, I exercised my discretion to allow Respondent to file a brief limited to these issues.

14 In my Order, I directed the Government to provide Respondent with a copy of its Request for Final Agency Action as well as the record submitted in support of its Request. Order, at 4.

While I adhere to that ruling in this matter, for future proceedings, I conclude that the waiver of the right to a hearing encompasses not only the waiver of the right to present evidence but the right to present legal arguments challenging the proceedings, including arguments challenging the sufficiency of the allegations, the sufficiency of the evidence, the Government's position on matters of law, and the appropriate sanction. In short, a party waiving its right to a hearing waives the right to be heard with respect to any issue under consideration.

Other Issues

As noted above, after Respondent waived its right to a hearing, the Government filed its Motion for Clarification. Therein, the Government sought clarification as to its obligations to provide copies of any documents submitted to me as well as whether Respondent had the right to continue to respond to its submissions. Mot. for Clarification, at 1-2.

Respondent objected to the Government's motion. In its Objection, it raised several contentions beyond those discussed above. Specifically, Respondent argued that once it waived its right to a hearing and the ALJ transmitted the record, the Government was not allowed to continue to litigate the proceeding. Resp.'s Objection, at 8-9. Respondent further argues that “the Government had the opportunity to submit facts and arguments or present evidence at a hearing but chose not to do so” even though it had the “right to participate in a hearing.” Id. at 6. Continuing, it argues that “the Government made a strategic decision to allow Respondent to file its written position and sit in silence when the ALJ announced he would cancel the hearing” and that “[t]he Government could have objected [sic] the cancellation of the hearing” or “presented its evidence in writing” but “chose to remains mute while plotting to attempt to present its case directly to the Administrator in ex parte communications.” Id. at 7. Thus, it argues that I must decide this matter based on the record transmitted to me by the ALJ. Finally, it argues that the Government has no basis for submitting its motion to me and that I have “no authority under DEA regulations or the APA to respond to the Government's Motion.” Id. at 9.

I reject Respondent's arguments. While it is true that Agency's procedural rules do not explicitly authorize the filing of a motion for clarification, the rules also do not explicitly authorize the filing of a variety of motions, including motions to enlarge the time to file a prehearing statement (which Respondent filed and the ALJ granted), motions to compel (which Respondent also filed but which the ALJ did not grant because Respondent did not make a sufficient showing to establish its entitlement to relief), and motions in limine.

Moreover, Respondent's position that while it was waiving its right to a hearing, it was entitled to continue to participate in the proceeding raised an issue of first impression. The Government was entitled to seek clarification of its obligations given the uncertainty created by Respondent's hearing waiver. As for Respondent's contention that I do not have authority to respond to the Government's motion, the APA specifically grants the Agency discretionary authority to “issue a declaratory order to . . . remove uncertainty.” 5 U.S.C. 554(e).

I also reject Respondent's contention that the Government is now foreclosed from presenting to me its evidence in support of the proposed revocation. In Respondent's view, the Government is simply a “person” under the Agency's regulation (21 CFR 1316.42(e)) entitled to a hearing or to participate in a hearing, or to submit a written statement of position. Respondent argues that “a hearing may only be cancelled if all persons entitled to a hearing or to participate in a hearing waive their opportunity to participate in a hearing.” Resp.'s Objection, at 6. It then argues that because “the Government has the burden of proof . . . it must participate if a hearing is held” and that “a hearing can occur even if some, but not all parties choose not to participate.” Id. And Respondent faults the Government for not objecting to the cancellation of the hearing or presenting its evidence in writing to the ALJ. Id. at 7.

Notwithstanding that 21 CFR 1316.42(e) defines the “[t]he term person [to] include[] an individual, corporation, government or governmental subdivision or agency,” when the Government initiates an Order to Show Cause proceeding, it is not a “person entitled to a hearing and desiring a hearing” within the meaning of 21 CFR 1316.47 (or 21 CFR 1301.43). Indeed, this language is fairly read as encompassing only the recipient of the Show Cause Order. See 21 CFR 1316.47 (“Any person entitled to a hearing and desiring a hearing shall, within the period permitted for filing, file a request for a hearing . . . .”); 21 CFR 1301.43(a) (“Any person entitled to a hearing pursuant to § 1301.32 or §§ 1301.34-1301.36 and desiring a heating shall, within 30 days after the date of receipt of the order to show cause . . . file with the Administrator a written request for a hearing in the form prescribed in § 1316.47 of this chapter.”) (emphasis added).

For the same reason, i.e., because it initiated the proceeding, when the Government initiates an Order to Show Cause proceeding, it is not a “person entitled to participate in a hearing pursuant to § 1301.34 or § 1301.35(b).” 21 CFR 1301.43(b). With respect to § 1301.34, this provision applies to a narrow category of cases which are not initiated by the Government—specifically where an applicant seeks a registration to import a schedule I or II controlled substance. Under this provision, the Agency is required to give notice to registered manufacturers as well as other applicants for registration to manufacturer the same basic substance, and upon request of such manufacturer or applicant, the Agency “shall hold a hearing on the application.” 21 CFR 1301.34(a). While the Government does not initiate the proceeding, it may intervene in the proceeding as a “person entitled to participate in a hearing.” 21 CFR 1301.43(b). See also e.g., Chattem Chemicals, Inc., 71 FR 9834, 9834 (2006), pet. for rev. denied sub nom. Penick Corp, Inc., v. DEA, 491 F.3d 483, 493 (D.C. Cir. 2007); Penick Corp., Inc., 68 FR 6947, 6947 (2003), pet. for rev. denied sub nom. Noramco, Inc., v. DEA, 375 F.3d 1148, 1159 (D.C. Cir. 2004). Indeed, this is the only circumstance in which the Government can be fairly described as a “person entitled to participate in a hearing.” 15

15 21 CFR 1301.43(b) also refers to the provisions of 1301.35(b), which allows for registered bulk manufacturers of a basic substance in schedule I or II (as well as applicants for registration to manufacture the basic substance) to “participate in a hearing” where the Government has issued a Show Cause Order proposing the denial of an application for registration “to manufacture in bulk” the same basic class and the applicant has requested a hearing. Here too, the Government is not a “person entitled to participate in a hearing.” Rather, it is the initiator of the proceeding.

As for its argument that the Government could have presented “its evidence at a hearing before the ALJ or filed . . . its written position on the matters of fact and law” with the ALJ, and thus, it should be barred from submitting its evidence to me, the Agency's longstanding and consistent practice is that where a party waives its right to a hearing, the Government is entitled to present its evidence directly to the Administrator, who is the ultimate factfinder. Cf. Reckitt & Colman, Ltd. v. Administrator, 788 F.2d 22, 26 (quoting 5 U.S.C. 557(b) (“On appeal from or review of the initial decision, the agency has all the powers which it would have in making the initial decision. . . .”)).

This is so, even where the respondent has initially requested a hearing but subsequently either waives its right to a hearing or is deemed to have waived its right to a hearing by failing to comply with an ALJ's orders. See Wheatland Pharmacy, 78 FR 69441 (2013) (explicit waiver); Al-Alousi, Inc., 70 FR 3561 (2005) (waiver deemed because of failure to file pre-hearing statement); J & P Distributor, 68 FR 43754 (2003) (withdrawal of hearing request); DuVall's Drug Store, Inc., 54 FR 15031 (1989) (“As a result of Respondent's withdrawal of the earlier request for a hearing, the Administrator concludes that Respondent has waived any opportunity for a hearing on the issues raised in the Order to Show Cause, and issues this final order based upon the information contained in the DEA investigative file.”); Faunce Drug Store, 47 FR 30122, 30122-23 (1982) (waiver of hearing based on failure to file prehearing statement; “[t]he law does not require this agency to go through the useless and wasteful exercise of convening a hearing for the presentation of both sides of the controversy when one side has failed to show that it has a case to be heard . . . . This Administration cannot permit the parties that appear before it to choose which orders to obey and which orders to disregard”).

Given Respondent's waiver of its right to a hearing, the Government was not required to put on its case before the CALJ or submit a written statement at that juncture. Rather, consistent with the Agency's longstanding practice, the Government was entitled to submit its Request for Final Agency Action and its supporting evidence directly to my Office.16

16 A different result might obtain had Respondent sought summary disposition in its favor. Under that circumstance, the Government would have clearly been on notice that it needed to oppose the motion and demonstrate through affidavits the existence of disputed material facts, and thus failure to provide such affidavits/declaration at that juncture could well have been fatal to the Government's case. Respondent did not, however, move for summary disposition.

While acknowledging that the CALJ's letter to the former Administrator “does not conform to the typical format of a recommended decision,” Respondent further argues that it is a recommended decision as “it provides a statement of reasoning and is clearly intended to constitute a transfer of the record to the Administrator.” Resp.'s Objection, at n.17. However, the CALJ's letter is not a recommended decision and does not purport to be a transmittal of the record.

The CALJ's letter is not titled as a recommended decision and most importantly, it does not contain any of the required elements of a recommended decision, which include “recommended findings of fact and conclusions of law, with reasons therefore; and [h]is recommended decision.” 21 CFR 1316.65(a)(2). Indeed, the CALJ made no recommendation with respect to how the Agency should decide this matter. CALJ Letter, at 4 (“I . . . accept its Statement of Position on the Agency's behalf, and herein forward it to you for whatever consideration or action (if any) you deem appropriate in this matter.”).

So too, the CALJ's letter contains no statement to the effect that it is the certification and transmittal of the record. Nor was the CALJ's letter accompanied by the pleadings of the parties (with the exception of the Respondent's statement), the CALJ's orders, or other materials such as a listing of the procedural exhibits and a docket sheet. And of course, it does not include any evidence other than the affidavits attached to Respondent's statement.

That the CALJ's letter does not certify the record is for good reason, as his duty to certify the record exists only when a proceeding goes to a hearing or is resolved through summary disposition. 21 CFR 1316.52. Upon Respondent's waiver of its right to a hearing, the CALJ's jurisdiction over the matter ceased. Indeed, in his letter to the prior Administrator, the CALJ specifically noted that “the authority of the administrative law judge commences and ends with the existence of a valid hearing request by one entitled to a hearing.” CALJ Letter, at 4. I therefore also reject Respondent's contention that I am foreclosed from considering the Government's Request for Final Agency Action and the evidence submitted in support thereof.

The Unexecuted Declaration

On review of the Government's submission, my Office noted that one of the declarations submitted by the Government had not been executed. On August 15, 2016, I issued an Order directing the Government to notify my Office as to whether an executed copy of the declaration existed. Order (Aug. 15, 2016). I further ordered the Government, if an executed copy exists, to provide the executed declaration as well as an explanation as to why the executed copy was not submitted with its Request for Final Agency Action. Id. I also ordered the Government to serve a copy of its response to my Order on Respondent and allowed Respondent to file a response to the Government's filing no later than five (5) business days from the date of receipt of the Government's filing. Id.

On August 18, 2016, the Government filed its response to my Order and a motion to supplement/correct the record. Therein, the Government represented that while the declaration had been executed “on August 28, 2015, and provided to Government counsel via email that same day[,] . . . the executed page was inadvertently omitted from the version of the declaration that was submitted to the Acting Administrator.' ” Government's Response to Order and Motion to Supplement/Correct the Record, at 1-2. The Government further moved to enter the executed declaration into the record arguing that there was “no prejudice” to Respondent. Id. at 2. In addition to providing a copy of the executed declaration, the Government attached a copy of an email from the Diversion Investigator, who was the affiant, which was sent to Government counsel on August 28, 2015 and has the subject line of “Last page of Affidavit.” Id. at 10. The email further states: “Attached is the last page of the affidavit with my signature per our conversation.” Id.

Respondent objects to the Government's motion. It argues that “[t]here is no precedent for the Administrator to allow the Government to establish the evidentiary foundation for documents in the Investigative File after the File has been transferred to the Administrator for final agency action.” Respondent's Response to the Government's Response to Order and Motion to Supplement the Record, at 2 (hereinafter, Response to Mot. to Supp.). It further argues that the Government is attempting to submit “additional evidence into the record” and that the Government has not made “the requisite showing . . . to reopen the record” or established “good cause.” Id. at 2-4 (citing 21 CFR 1319.57, a regulation which does not exist). And Respondent also contends that it would be prejudiced if I “allowed the Government to enter the [s]ignature [p]age into the record of these proceedings.” Id. at 5.

According to Respondent, “[o]nce the Investigative File is transferred to [me] for final agency action, the Investigative File (and any pleadings or written statements) constitutes the record on which the” final decision must be based. Id. at 3. Respondent then argues that the Government is seeking to reopen the record and therefore, the Government must show that the evidence “was previously unavailable” and that it “would be material and relevant to the matter in dispute.” Id. And Respondent contends that the Government's representation that it had received the signature page on August 28, 2015 but inadvertently failed to include the page when it submitted the Investigative File establishes that the evidence was available to the Government when it submitted the declaration. Id.

Contrary to Respondent's understanding, unlike in a proceeding conducted by an Administrative Law Judge, no rule of the Agency specifies the point at which the record is closed and can only be supplemented by filing a motion to re-open and demonstrating that the evidence was previously unavailable. Cf. 21 CFR 1316.65(c) (“Not less than twenty-five days after the date on which he caused copies of his report to be served upon the parties, the presiding officer shall certify to the Administrator the record. . . .”). Indeed, where a party has waived its right to a hearing and the Government has submitted a Request for Final Agency Action, the Government has, on occasion, filed a supplement to its Request for Final Agency Action and included additional information regarding criminal and state board proceedings. See Keith Ky Ly, 80 FR 29025, 29032 (2015); Algirdas J. Krisciunas, 76 FR 4940, 4941 n.3 (2011). As long as due process is not offended, such filings and the accompanying evidence have been accepted into the record without requiring any showing that the evidence was previously unavailable.17

17 Respondent cites several Agency cases in support of its contention that a party must demonstrate that the evidence was previously unavailable when seeking to re-open the record. Respondent's Response to Government's Response to Order and Motion to Supplement the Record, at 3 (citing Wesley G. Harline, 64 FR 72678 (1999); Robert M. Golden, 61 FR 24808 (1996); Bienvenido Tan, 76 FR 17673 (2011)). However, in each of these proceedings, a hearing had been conducted by an ALJ and the record had been certified by the ALJ and transmitted to the Office of the Administrator/Deputy Administrator. See Harline, 64 FR at 72684-85; Golden, 61 FR at 24808. Moreover, in Tan, the ALJ had conducted the hearing and issued her recommended decision when the respondent sought to admit an affidavit addressing the ALJ's findings that he had failed to address several critical deficiencies identified by the ALJ in her decision. 76 FR at 17675. Thus, at that stage of the proceeding, the only remaining step for the ALJ (other than to address the respondent's request to re-open) was to certify and transmit the record.

In any event, the declaration is not additional evidence. Rather, but for an executed signature page, the same exact declaration was submitted by the Government with its Request for Final Agency Action and the Government was directed to serve a copy of its filing on Respondent.18 Notably, Respondent did not move to strike the declaration as originally filed by the Government. Nor in its Reply to the Government's Request for Final Agency Action did Respondent raise any issue as to the validity of the declaration. Cf. Noblett v. General Electric Credit Corp., 400 F.2d 442, 445 (10th Cir. 1968) (holding that “[a]n affidavit that does not measure up to the standards of [old rule] 56(e) is subject to a motion to strike; and formal defects are waived in the absence of a motion or other objection”).

18 No claim is raised by Respondent that the Government failed to provide it with the declaration when it was served with the Request for Final Agency Action.

Respondent further argues that I should not accept the signed declaration because the Government has not established good cause 19 but only that it “inadvertently omitted” the signature page when it submitted the Request for Final Agency Action.20 Response to Mot. to Supp., at 4. While Respondent argues that “agency precedent does not recognized simple inadvertence as good cause,” id. at 5; it is mistaken. For example, in Tony Bui, 75 FR 49979, 49980 (2010), the respondent's counsel used an incomplete address when he mailed the hearing request resulting in the hearing request being returned to respondent's counsel, and when the latter re-submitted the request, it was received out of time. While not specifically using the word “inadvertence” to describe the act of Respondent's counsel, the Agency nonetheless upheld the ALJ's ruling that good cause had been shown to excuse the untimely filing.21

19 Respondent cited to 21 CFR 1316.57 as support for its contention that the Government was required to establish “good cause” to accept its untimely filing. Respondent's Resp. to Motion to Supplement, at 4-5. This regulation applies, however, only where a hearing is being conducted by an ALJ. Nonetheless, for the purpose of this decision, I assume, without deciding that the “good cause” standard applies to the Government's motion.

20 Actually, the Government did submit the signature page with its Request for Final Agency Action. The problem was that the page that was submitted did not include the DI's signature and date.

21 Nor is this the only instance in which the Agency has excused negligent or inadvertence on the part of a respondent's attorney. In Mark S. Cukierman, Denial of Government's Interlocutory Appeal, 8-11 (No. 12-67) (unpublished), the Agency held that a respondent had established good cause to excuse the untimely filing of a hearing request when the attorney's assistant was directed to, but failed to file a hearing request before going on vacation, and on the due date, the attorney was unable to verify that the request was filed because he was undergoing dental surgery. Slip. Op., at 10. The Agency held that there was good cause notwithstanding that it found that “Respondent's counsel should have been more diligent in supervising his subordinate to ensure that she had filed the request.” Id.

To be sure, in determining whether to excuse an untimely filing, these cases have also looked at such factors as whether the offending party promptly corrected its omission and whether the opposing party was prejudiced. As for the first of these factors, upon being notified of the issue the Government has promptly corrected the omission. Cf. Fed. R. Civ. P. r.11 (a) (“The court must strike an unsigned paper unless the omission is promptly corrected after being called to the attorney's or party's attention.”).22

22 Even if this provision does not apply to affidavits or declarations, it nonetheless supports the notion of allowing a party to correct an oversight with respect to its filing as long as it acts promptly. Of further note is Fed. R. Civ. P. r. 56(e)(1). It provides that “[i]f a party fails to properly support an assertion of fact or fails to properly address another party's assertion of fact as required by Rule 56(c), the court may . . . give an opportunity to properly support or address the fact[.]”

Respondent further argues that it will be prejudiced if the new declaration is admitted. Response to Mot. to Supp., at 5. Yet it makes no assertion that actually establishes prejudice. While the Government, in its Request for Final Agency Action, argued that Respondent failed to maintain accurate records and failed to electronically link CSOS records and specifically relied on the declaration, Respondent, in its Response to the Request for Final Agency Action, did not address the various recordkeeping allegations at all. Compare Request for Final Agency Action, at 28-30, with Respondent's Response to Request for Final Agency Action, at 2-27. Notably, Respondent offered no explanation as to why it did not address the allegations for which the declaration was offered, let alone argue that it deemed it unnecessary to do so because the declaration was legally insufficient.

Moreover, even now in response to the Government's Motion to admit the signed declaration, Respondent does not maintain that it will be prejudiced because when it prepared its response to the Request for Final Agency Action, it determined that the unsigned declaration was not legally sufficient to provide evidentiary support for those allegations and therefore did not address them. See Resp. to Gov. Response to Order and Motion to Supplement the Record, at 5-6. In short, because Respondent offers only conclusory assertions of prejudice, I accept the signed the declaration into the record.23

23 Respondent further argues that it “believes that the Signature Page itself and the accompanying email [submitted by the Government] raise issues” and that it “cannot identify any point of relation between the Signature Page and the email to indicate that the two documents have any connections to each other whatsoever.” Response to Gov. Motion to Supplement the Record, at 4. Respondent further suggests that testimony or additional documentary evidence may be necessary to link the two documents. Id.

The Government, however, has submitted to me the entire declaration, which is signed and dated below the statement: “I hereby declare under penalty of perjury that the forgoing is true and correct pursuant to 28 U.S.C. 1746.” GA 2, at 6 (corrected). As the declaration has been signed and dated under the penalty of perjury, I deem it unnecessary to inquire into the “connections” between the email and the signature page.

Respondent's Surrender of Its Registration and Withdrawal Request

On August 30, 2016, Counsel for Respondent notified my Office that it would surrender its DEA Certificate of Registration effective at 11:59 p.m. that day. Letter from D. Linden Barber, Esq., to the Acting Administrator, at 1 (Aug. 30, 2011). Respondent's Counsel also advised that it had returned its unused order forms to the DEA Tampa Office and that it had delivered its controlled substances to a reverse distributor. Id.

While Respondent's surrender of its registration rendered moot the issue of whether its registration should be revoked, during the course of the proceeding Respondent filed a renewal application. No regulation of the Agency provides that the surrender of a registration also acts as the withdrawal of a pending application. To the contrary, under an Agency regulation, when an applicant has been served with a show cause order, the applicant must either show that “good cause” exists to allow it to withdraw its application or that “withdrawal is in the public interest.” 21 CFR 1301.16(a). Accordingly, my Office notified Respondent by email (which was copied to the Government) that for the matter to be dismissed, Respondent needed to request permission to withdraw its application. See 21 CFR 1301.16(a). My Office thus directed Respondent to address whether it was willing to withdraw its application.

Thereafter, Respondent's Counsel filed a letter requesting withdrawal. Letter from D. Linden Barber, Esq., to the Acting Administrator, at 1 (Aug. 31, 2011). Therein, Respondent's Counsel argued that withdrawal of its application “is in the public interest as it accomplishes DEA's purpose in issuing the Order to Show Cause, namely, removing [Respondent's] authority to handle controlled substances.” Id. Having considered Respondent's showing, I conclude that granting its withdrawal request is not “in the public interest.” 21 CFR 1301.16(a).

The Agency has set forth several factors it considers in determining whether the granting of a request to withdraw is in the public interest. See Vincent G. Colisimo, 79 FR 20911 20913 (2014); Liddy's Pharmacy, L.L.C., 76 FR 48887, 48888 (2011). These factors include the potential prejudice to the Government were the request granted, the nature of the misconduct, the extent to which the Agency's resources have been expended in the litigation and review of the matter, whether the respondent has remained in business or professional practice, and whether the respondent has agreed to not reapply for registration. See Colisimo, 79 FR at 20913; Liddy's, 76 FR at 48888.

To be sure, Respondent's surrender of its registration serves the public interest to some degree by ending its authority to handle controlled substances. The Controlled Substances Act does not, however, prohibit a former registrant from reapplying for a registration for any particular period of time, and in fact, a former registrant can reapply immediately following its surrender of a registration. Notably, Respondent's counsel has represented only that his client “ha[s] no intention of applying for a DEA Registration in the near future.” Letter from D. Linden Barber, Esq., to the Acting Administrator, at 1 (Aug. 30, 2016). Thus, it is clear that Respondent intends to remain in business and reapply for a DEA registration.

Moreover, my Office has expended substantial resources in the review of this matter and the preparation of this Decision and Order. See id. As discussed below, that review has determined that Respondent's pharmacists committed egregious violations of the Controlled Substances Act.24 However, were I to grant its request to withdraw, Respondent would escape the consequences of the findings of fact and legal conclusions that are warranted by the record in this proceeding. Under these circumstances, the potential prejudice to the Government is substantial and the harm to the public interest is manifest. See Bobby D. Reynolds, et al., 80 FR 28643, 28643 n.2 (2015). I therefore conclude that granting Respondent's request to withdraw its application is not in public interest. 21 CFR 1301.16(a). I also conclude that Respondent has not demonstrated “good cause” to allow it to withdraw.

While Victor Obi was a consultant to both Hills Pharmacy and Edge Pharmacy and participated in both proceedings by attending the hearing in Hills and providing an affidavit in Edge, the record in Edge does not establish that he was actively involved in the operation and management of the latter pharmacy. Thus, notwithstanding the familial links, the findings rendered in my decisions regarding the misconduct committed by Superior Pharmacies I and II and Hills would likely not be entitled to preclusive effect were Edge Pharmacy to apply for a new registration and could cause substantial prejudice to the Government.

Having considered the record submitted by the Government, and the parties' legal arguments as to the sufficiency of the evidence, I make the following findings of fact.

Findings of Fact

Respondent is licensed by the Florida Board of Pharmacy as a Community Pharmacy. For much of this proceeding, Respondent was also the holder of DEA Certificate of Registration FE1512501, pursuant to which it was authorized to dispense controlled substances in schedules II through V as a retail pharmacy, at the registered address of 2039 E. Edgewood Drive, Lakeland, Florida. According to the registration records of the Agency, while Respondent's registration was due to expire on August 31, 2015, on July 8, 2015, it submitted a timely renewal application. This action kept its registration in effect until August 30, 2016, see 21 CFR 1301.36(i), when Respondent surrendered its registration. Letter from D. Linden Barber, Esq., to the Acting Administrator, at 1 (Aug. 20, 2016); see also 21 CFR 1301.36(i).

However, while Respondent no longer holds a registration, for reasons explained previously, Respondent's application remains pending in this proceeding. This precludes a finding of mootness. See Liddy's Pharmacy, L.L.C., 76 FR at 48888.

Respondent is owned by Harrieth Aladiume. Gov. Declaration (hereinafter, GA) 3, at 1. Ms. Aladiume's brother is Victor Obi-Anadiume. Id. Mr. Obi-Anadiume is the owner of several pharmacies in the Tampa Bay area, including two pharmacies whose registrations I recently revoked.25See Superior Pharmacy I and Superior Pharmacy II, 81 FR 31309, 31341 (2016). Mr. Obi-Anadiume is also the owner of a third Tampa pharmacy (Jet Pharmacy); on March 31, 2015, Mr. Obi surrendered Jet's registration for cause.26 GA 3, at 2.

In addition, Mr. Obi-Anadiume owns or owned two pain clinics: (1) 24th Century Medical Clinic, located at 7747 W. Hillsborough Ave., Tampa, Fl., and (2) MD Plus Clinic, located at 2039 Edgewood Drive, Suite 110B, Lakeland, Fl. Id. The MD Plus Clinic was located in a suite adjacent to that occupied by Respondent. Id.; see also Gov. Declaration 1, Attachment B, at 1. On or about October 15, 2012, the State of Florida, Agency for Health Care Administration, served the MD Plus Clinic with an administrative complaint which sought to revoke its health care clinic license and impose administrative fines. GA 1, Attachment B, at 12-13. On March 26, 2013, Mr. Obi-Anadiume entered into a settlement agreement with the State on MD Plus's behalf, pursuant to which he surrendered its license.27Id. at 14, 18.

27 The record does not include the complaint, and in any event, Mr. Obi was not required to admit to any of the allegations. GA 1, Attachment B, at 15.

The Dispensing Allegations

On February 4, 2013, DEA Investigators executed an Administrative Inspection Warrant (AIW) at Respondent, pursuant to which they seized the schedule II prescriptions and other documents pertaining to Respondent's purchases and distributions of controlled substance. GA 3, at 1-2. The Investigators also created a mirror image of Respondent's computer data. Id. at 2. A review of the data showed that from January 1, 2011 through February 4, 2013, more than 93 percent of the schedule II dosage units dispensed by Respondent (463,392 out of 497,104 du) were dispensed pursuant to prescriptions written by six doctors employed by Mr. Obi-Anadiume, and nearly 85 percent of the dosage units were filled pursuant to prescriptions written by a single doctor, Victor Thiagaraj Selvaraj.28 GE 10, at 1. The data also showed that 27 doctors (other than those employed by Mr. Obi) prescribed the remaining dosage units (33,742 du) dispensed by Respondent). Id.

28 According to the online records of the Florida Department of Health (DOH), of which I take official notice, Dr. Selvaraj was Board Certified in Family Medicine but not pain medicine or anesthesiology. See 5 U.S.C. 557(c). Of further note, on November 5, 2013, the DOH ordered the emergency restriction of Dr. Selvaraj's license to practice medicine based on findings which included that he “prescrib[ed] large quantities and types of Schedule II-IV controlled substances to Patients without adequate supporting documentation and without any legitimate medical purpose.” In re: The Emergency Restriction of the License of Victor Thiagaraj Selvaraj, M.D., at 65 (Fla. DOH, Nov. 5, 2013) (No. 2012-04201). The Board further concluded that “Dr. Selvaraj violated Section 458.331(1)(q), Florida Statutes,” which prohibits “[p]rescribing, dispensing, [or] administering . . . any controlled substance, other than in the course of the physician's professional practice.” Id. at 73.

Of further note, on March 21, 2016, Dr. Selvaraj voluntarily relinquished his medical license “to avoid further administrative actions” and “agree[d] to never reapply for licensure as a Medical Doctor in the State of Florida.” See Voluntary Relinquishment of License, at 1, In re: The License of Victor Thiagaraj Selvaraj, M.D. (Mar. 22, 2016). On August 16, 2016, the Florida Board of Medicine accepted Dr. Selvaraj's offer to voluntarily relinquish his medical license. See id. at Final Order, at 1-2.

According to one of the Investigators, following the seizure of the prescriptions, the prescriptions and their labels were scanned electronically and provided to Robert Parrado, R.Ph., who reviewed them and provided his opinion. GA 2. Mr. Parrado holds a Bachelor of Science in Pharmacy from the University of Florida and has been licensed as pharmacist in Florida since 1971. GA 1, at 1. Mr. Parrado has practiced as a pharmacist in both the hospital and community pharmacy setting and owned two pharmacies for approximately 19 years. Id.

Mr. Parrado was a member of the Florida Board of Pharmacy from December 2000 through February 2009 and served as both its Vice-Chairman (in 2003) and Chairman (in 2004). Id. While on the Board, he “presided over numerous disciplinary matters,” including some which involved the diversion of controlled substances. Id. Mr. Parrado testified that he is familiar with both federal and state laws and regulations applicable to the prescribing and dispensing of controlled substances including 21 CFR 1306.04(a); Florida Stat. Ann. §§ 465.016(1)(i), 465.023(1)(h), and 893.04(2)(a), and Fla. Admin. Code r.64B16-27.831. Id. at 1-2.

Mr. Parrado then opined as to the various steps a Florida pharmacist must take to ensure that any prescription “is written pursuant to an appropriate physician-patient relationship, as well as being clinically appropriate and safe to dispense.” Id. at 2. These included reviewing “the patient's age, gender, address, current or previous medical conditions, drug allergies and condition being treated, [the] physician's address and specialty or area of practice,” the “appropriateness of therapy” and whether there is “any therapeutic duplication.” Id. In addition, Mr. Parrado testified that the prescription must be reviewed to determine if it contains all required information including the patient's name and address, the prescriber's name and address, the prescriber's DEA number, the drug name, dosage form, strength, quantity, and instructions for use. Id.

Mr. Parrado further opined that when a controlled substance prescription is presented, a pharmacist must take additional steps to verify the legitimacy of the prescription and prevent potential abuse and diversion. Id. These include “reviewing the quantity of the medication prescribed; appropriate dosage; the location of the patient's home from the physician and/or the pharmacy; trends in the physician's prescribing habits; and the number of pharmacies the patient has used for similar medications.” Id. at 2-3. Mr. Parrado then opined that “a reasonably prudent” Florida pharmacist “must be familiar with” various indicia that create a suspicion that a controlled substance prescription may be abused or diverted. Id. Mr. Parrado termed these indicia “red flags” and explained that “a `red flag' is anything about a prescription that would cause the pharmacist to be concerned that the prescription was not issued for a legitimate medical purpose in the usual course of professional practice.” These include:

1. There is a significant distance between the addresses of the patient and the prescriber and/or the pharmacy;

2. The prescription is for the highest strength and/or large quantities;

3. Multiple patients arrive at the pharmacy in close temporal proximity and present similar prescriptions which were issued by the same physician or clinic;

4. Patients are willing to pay large amounts using cash or cash equivalents (check or credit card) for narcotics when the same drugs are available at other pharmacies for lower prices;

5. The prescriber writes similar prescriptions for each patient for “narcotics in identical or nearly identical quantities . . . regardless of the patient's individualized medical conditions”;

6. The prescriber issues cocktail prescriptions for such drugs as oxycodone, benzodiazepines, and carisoprodol;

7. The prescriber issues prescriptions for “two or more” drugs which are “known to treat the same condition in the same manner,” such as two immediate release opioids.

Id. at 3-4.

Mr. Parrado testified that “[w]hen confronted with a red flag or red flags concerning a prescription for controlled substances, a pharmacist must try to resolve the red flags to determine whether . . . the prescriptions is legitimate” and must do so “prior to filling the prescription.” Id. at 4. He testified that the steps taken depend on the type of red flag and may include questioning the patient and/or contacting the physician. Id. He also testified that “[w]hen a pharmacist contacts a physician to address red flags presented by the prescription, the standard practice in Florida is for the pharmacist to note it on the prescription” and “[i]f there is no documentation on the prescription addressing the red flag and resolving the red flag, you can assume that the red flag was not resolved.” Id.

Mr. Parrado further testified that “[w]hile some red flags can be resolved, there are other red flags (or combination and patterns of red flags) that a pharmacist cannot resolve by contacting the physician, running a State prescription monitoring search, or obtaining more information from the patient.” Id. As an exam